Systems and methods for heart valve therapy

ABSTRACT

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. For example, this document describes prosthetic heart valve designs and techniques that reduce or prevent obstructions of the left ventricular outflow tract that may otherwise result from systolic anterior motion of an anterior leaflet of the native mitral valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/072,588, filed Mar. 17, 2016, which claims the benefit of U.S.Provisional Application Ser. No. 62/135,276, filed Mar. 19, 2015. Thedisclosure of the prior applications are considered part of (and areincorporated by reference in) the disclosure of this application.

TECHNICAL FIELD

This document relates to prosthetic heart valves, such as prostheticmitral valves that can be implanted using transcatheter techniques.

BACKGROUND

The long-term clinical effect of valve regurgitation is recognized as asignificant contributor to cardiovascular related morbidity andmortality. Thus, for many therapies intended to treat the mitral valve,one primary goal is to significantly reduce or eliminate regurgitation.By eliminating the regurgitation at the mitral valve, the destructivevolume overload effects on the left ventricle can be attenuated. Thevolume overload of mitral regurgitation (MR) relates to the excessivekinetic energy required during isotonic contraction to generate overallstroke volume in an attempt to maintain forward stroke volume andcardiac output. It also relates to the pressure potential energydissipation of the leaking valve during the most energy-consumingportion of the cardiac cycle, isovolumetric contraction. Additionally,therapies for MR reduction can have the effect of reducing the elevatedpressures in the left atrium and pulmonary vasculature reducingpulmonary edema (congestion) and shortness of breath symptomatology.Such therapies for MR reduction may also have a positive effect on thefilling profile of the left ventricle (LV) and the restrictive LVphysiology that can result with MR. These pathophysiologic issuesindicate the potential benefits of MR therapy, but also indicate thecomplexity of the system and the need for a therapy to focus beyond theMR level or grade.

Some therapies for treating MR may worsen other (non-MR) existingpathologic conditions or create new pathologic conditions. One of theconditions to be managed is left ventricular outflow tract (LVOT)obstruction, or creation of high LVOT pressure gradients. Someimplementations of prosthetic valve systems may physically obstruct theLVOT, and some benefits of MR reduction may thereby be dissipated orlost. Further, in some implementations of prosthetic valve systems,systolic anterior motion (SAM) of the native mitral valve leaflet(s) maycause LVOT obstruction or the creation of high LVOT pressure gradients.For example, in some cases SAM is the incursion of an anterior leafletof the native mitral valve into the LVOT during systole.

When a prosthetic valve is implanted in a native mitral valve withoutremoval or other restraint of the native valve leaflets, the anteriorleaflet may be exposed to different flow conditions which may actually“pull” the anterior leaflet, via Bernoulli forces, toward and into theLVOT. If the anterior leaflet is drawn too far into the LVOT, there isrisk of it significantly interfering with the outflow, creating asignificant clinical concern. There is therefore a potential benefit toincorporating features on a prosthetic valve system to minimize thepotential for SAM.

SUMMARY

This document describes prosthetic heart valves, such as prostheticmitral valves that can be implanted using transcatheter techniques. Forexample, some embodiments of a transcatheter mitral valve deliverysystem and method described herein can be deployed to interface andanchor in cooperation with the native anatomical structures of a mitralvalve. In addition, this document describes prosthetic heart valvesystems and techniques that, in particular embodiments, are configuredto reduce or prevent the potential for full or partial blockages of theLVOT by SAM of the anterior leaflet of the native mitral valve.

In some implementations, a prosthetic mitral valve includes a valveassembly and an anchor assembly. The anchor assembly may be configuredto selectively couple with the valve assembly. The valve assembly maycomprise an expandable valve frame and an occluder attached to theexpandable valve frame. The anchor assembly may comprise an expandableanchor frame comprising a systolic anterior motion (SAM) containmentmember. The SAM containment member may be configured to be at leastpartially disposed behind (on an aortic side of) an anterior leaflet ofa native mitral valve when the expandable anchor frame is engaged withthe native mitral valve.

Such a prosthetic mitral valve may optionally include one or more of thefollowing features. In some embodiments, the anchor assembly comprises aplurality of sub-annular projections configured to engage tissueproximate to an annulus of the native mitral valve. A space may bedefined between an outwardly facing periphery of the valve assembly andthe SAM containment member. Such a space may be configured to looselycontain the anterior leaflet when the prosthetic mitral valve system isengaged with the native mitral valve. In particular embodiments, SAMcontainment member comprises an elongate member with a first end thatextends from a first portion of the expandable anchor frame and a secondend that extends from a second portion of the expandable anchor frame.In various embodiments, the SAM containment member further comprises anattachment element. The prosthetic mitral valve system may furthercomprise a delivery system for deploying the anchor assembly. Thedelivery system may comprise a catheter configured to engage with theattachment element. In some embodiments, the prosthetic mitral valvesystem may further comprise a delivery system for deploying the anchorassembly. The delivery system may comprise a control wire configured toengage with the attachment element. In various embodiments, the SAMcontainment member comprises an elongate member that extends from a hubof the expandable anchor frame, and wherein the elongate member definesa first width. Optionally, the SAM containment member may include an endportion extending from the elongate member. The end portion may define asecond width that is greater than the first width of the elongatemember, and the end portion may be configured to be disposed behind theanterior leaflet when the expandable anchor frame is engaged with thenative mitral valve. In particular embodiments of the prosthetic mitralvalve system, the expandable anchor frame may include a single SAMcontainment member.

In another implementation, a prosthetic mitral valve system comprises anexpandable frame with an occluder coupled thereto, and a delivery systemfor transcatheter deployment of the expandable frame within a nativemitral valve. The expandable frame may comprise a systolic anteriormotion (SAM) containment member that is configured to be at leastpartially disposed behind an anterior leaflet of the native mitral valvewhen the expandable frame is engaged with the native mitral valve. TheSAM containment member may comprise an attachment element. The deliverysystem may be releasably coupleable with the attachment element.

Such a prosthetic mitral valve system may optionally include one or moreof the following features. In some embodiments, the attachment elementcomprises an eyelet. Optionally, the eyelet includes eyelet threads. Insome embodiments, the delivery system comprises a member with threadsthat are complementary with the eyelet threads. In particularembodiments, the delivery system comprises a control wire that engageswith the eyelet. In various embodiments, the SAM containment membercomprises an elongate member that extends from a hub of the expandableframe. The elongate member defines a first width. In particularembodiments, the SAM containment member includes an end portionextending from the elongate member, and the end portion defines a secondwidth that is greater than the first width of the elongate member. Theend portion may be configured to be disposed behind the anterior leafletwhen the expandable anchor frame is engaged with the native mitralvalve. Optionally, the expandable frame includes a single SAMcontainment member.

In another implementation, a method for deploying a prosthetic mitralvalve system within a native mitral valve of a patient includes:navigating a delivery sheath of a prosthetic mitral valve deliverysystem within the patient such that a distal end of the delivery sheathis positioned adjacent the native mitral valve; expressing an anchorassembly of the prosthetic mitral valve system from the distal end ofthe delivery sheath such that the anchor assembly at least partiallyexpands, the anchor assembly configured to selectively mate with a valveassembly of the prosthetic mitral valve system; engaging the anchorassembly with the native mitral valve; and after engaging the anchorassembly with the native mitral valve, deploying a systolic anteriormotion (SAM) containment member such that the SAM containment memberbecomes at least partially disposed behind an anterior leaflet of thenative mitral valve.

Such a method may optionally include one or more of the followingfeatures. The method may further comprise, after deploying the SAMcontainment member, mating the valve assembly with the anchor assembly.In some embodiments, the method may further comprise, prior to deployingthe SAM containment member, mating the valve assembly with the anchorassembly. In particular implementations, when the anchor assembly isengaged with the native mitral valve, and prior to deploying the SAMcontainment member, native leaflets of the native mitral valve continueto function without significant interference from the anchor assembly.In various implementations, wherein when the anchor assembly is engagedwith the native mitral valve, and after deploying the SAM containmentmember, native leaflets of the native mitral valve continue to functionwithout significant interference from the anchor assembly. Optionally,the anchor assembly comprises one or more sub-annular support arms eachhaving an anchor foot. In some implementations, engaging the anchorassembly with the native mitral valve comprises disposing each anchorfoot within a sub-annular gutter of the native mitral valve. In someembodiments, the method may further comprise mating the valve assemblywith the anchor assembly, wherein the anterior leaflet is looselycontained between the SAM containment member and an exterior surface ofthe valve assembly. Optionally, the SAM containment member is biased tobe at least partially disposed behind the anterior leaflet. Deployingthe SAM containment member may comprise detaching the SAM containmentmember from a member of the prosthetic mitral valve delivery system suchthat the SAM containment member is free to self-reconfigure to become atleast partially disposed behind the anterior leaflet. In someembodiments, deploying the SAM containment member comprises using amember of the prosthetic mitral valve delivery system to deflect the SAMcontainment member to be at least partially disposed behind the anteriorleaflet.

In another implementation, a method for transcatheter deployment of aprosthetic mitral valve within a native mitral valve of a patientincludes engaging the prosthetic mitral valve with the native mitralvalve, and after engaging the prosthetic mitral valve with the nativemitral valve, deploying a systolic anterior motion (SAM) containmentmember of the prosthetic mitral valve such that the SAM containmentmember becomes at least partially disposed behind an anterior leaflet ofthe native mitral valve. In some implementations of the method, theanterior leaflet is loosely contained between the SAM containment memberand an exterior surface of the prosthetic mitral valve. Optionally, theSAM containment member is biased to be at least partially disposedbehind the anterior leaflet. Deploying the SAM containment member maycomprise detaching the SAM containment member from a delivery systemmember such that the SAM containment member is free to self-reconfigureto become at least partially disposed behind the anterior leaflet. Insome implementations, portions of the SAM containment member engage oneor more lateral edges of the anterior leaflet or chordae to spread orwiden the anterior leaflet to thereby restricting movement of theanterior leaflet.

In another implementation, an anchor assembly of a prosthetic mitralvalve system includes an expandable anchor frame that is adjustablebetween a radially compressed delivery condition and a radially expandeddeployed condition in which the expandable anchor frame is configured toengage with a native mitral valve. The anchor assembly may be configuredto selectively mate with a subsequently deliverable valve assembly of aprosthetic mitral valve system. The expandable anchor frame may includea systolic anterior motion (SAM) containment member that is configuredto be at least partially disposed behind an anterior leaflet of thenative mitral valve when the expandable anchor frame is engaged with thenative mitral valve.

Such an anchor assembly may optionally include one or more of thefollowing features. In some embodiments, the SAM containment membercomprises an elongate member with a first end that extends from a firstportion of the expandable anchor frame and a second end that extendsfrom a second portion of the expandable anchor frame. Optionally, theSAM containment member further comprises an attachment elementconfigured to releasably engage with a portion of a delivery system. Inparticular embodiments, the attachment element comprises an eyelet. Invarious embodiments, the SAM containment member comprises an elongatemember that extends from a generally central, lower hub of theexpandable anchor frame. The elongate member defines a first width. Insome embodiments, the SAM containment member includes an end portionextending from the elongate member. In particular embodiments, the endportion defines a second width that is greater than the first width ofthe elongate member. Optionally, the end portion is configured to bedisposed behind the anterior leaflet when the expandable anchor frame isengaged with the native mitral valve. In some embodiments, theexpandable anchor frame includes a single SAM containment member.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of the prostheticmitral valve systems provided herein can be used in a completelypercutaneous/transcatheter mitral replacement procedure that is safe,reliable, and repeatable by surgeons and/or interventional cardiologistsof a variety of different skill levels. For example, in someimplementations the prosthetic mitral valve system can establish areliable and consistent anchor/substrate to which the valve/occluderstructure subsequently engages. Thus, the prosthetic mitral valve systemcan be specifically designed to make use of the geometry/mechanics ofthe native mitral valve to create sufficient holding capability. In oneparticular aspect, the anatomical gutter found below a native mitralvalve annulus can be utilized as a site for anchoring the prostheticmitral valve system, yet the anchoring structure can be deployed in amatter that maintains native leaflet function of the mitral valve,thereby providing the ability to completely separate and stage theimplantation of the components of the prosthetic mitral valve system.Accordingly, some embodiments of the prosthetic mitral valve systemsdescribed herein are configured to be implanted in a reliable,repeatable, and simplified procedure that is broadly applicable to avariety of patients and physicians, while also employing a significantlyless invasive method.

Second, in particular embodiments, the prosthetic mitral valve systemcan include two different expandable components (e.g., an anchorassembly and a valve assembly) that are separately delivered to theimplantation site, and both components can abut and engage with nativeheart tissue at the mitral valve. For example, the first component(e.g., the anchor assembly) can be configured to engage with the hearttissue that is at or proximate to the annulus of the native mitralvalve, and the second component (e.g., the valve assembly) can beconfigured to provide a seal interface with native valve leaflets of themitral valve.

Third, some embodiments of the prosthetic mitral valve systems describedherein are configured with a SAM containment member feature. Multipletypes of SAM containment members are described herein. SAM containmentmembers can reduce or prevent the potential for a natural mitral valveanterior leaflet to “flop” outward and/or from being drawn by a Venturieffect into the LVOT. Accordingly, the SAM containment members canreduce the risk of full or partial blockages of the LVOT. In somepatient scenarios, the potential for suffering future adverse healthevents, such as heart failure, is thereby reduced.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a portion of a prosthetic mitral valvedeployment system in a cross-sectional view of a native human heart, inaccordance with some embodiments.

FIG. 2 shows a perspective view of a prosthetic mitral valve anchorassembly in the left atrium of the heart after the anchor assembly hasemerged from an anchor delivery sheath of the deployment system of FIG.1

FIG. 3 shows a perspective view of the anchor assembly of FIG. 2 afterbeing rotated in the left atrium so as to orient the anchor assemblygenerally perpendicular to the native mitral valve.

FIG. 4 shows a perspective view of the anchor assembly of FIG. 3 afterbeing partially advanced through the native mitral valve so as toposition projections of the anchor assembly below a sub-annular gutterof the native mitral valve.

FIG. 5 shows a perspective view of the anchor assembly in a similararrangement as shown in FIG. 4, but in a commissural cross-sectionalview of the heart (from the left side of the heart).

FIG. 6 shows a perspective view of the anchor assembly of FIG. 5 afterbeing retracted so as to position the projections of the anchor assemblyin the sub-annular gutter of the native mitral valve.

FIG. 7 shows a perspective view of the anchor assembly of FIG. 6 afterthe retraction of some members of the deployment system.

FIG. 8 is a top view of a native mitral valve and depicts a gutterperimeter of the sub-annular gutter of FIG. 7 (without the anchorassembly).

FIG. 9 shows a perspective top view of an example anchor assembly ofFIGS. 2-7, including an example SAM containment member in a pre-deployedconfiguration, in accordance with some embodiments.

FIG. 10 shows a perspective top view of the example anchor assembly ofFIG. 9, with the SAM containment member is a deployed configuration, inaccordance with some embodiments.

FIG. 11 shows a perspective top view of an example anchor assembly,including another example SAM containment member in a deployedconfiguration, in accordance with some embodiments.

FIG. 12 shows a perspective top view of the anchor assembly of FIG. 10with a covering material disposed on portions of the anchor frame.

FIG. 13A shows a perspective top view of the anchor assembly of FIG. 10implanted within a native mitral valve (with the native mitral valveleaflets in a closed state), and FIG. 13B shows a correspondinganatomical top view of the anchor assembly of FIG. 13A.

FIG. 14A shows a perspective top view of the anchor assembly of FIG. 10implanted within the native mitral valve of FIG. 13A (with the nativemitral valve leaflets in an open state), and FIG. 14B shows acorresponding anatomical top view of the anchor assembly of FIG. 14A.

FIG. 15 shows a perspective view of the anchor assembly of FIG. 7implanted within the native mitral valve and a valve assembly deliverysheath extending into the left atrium.

FIG. 16 shows a perspective view of a valve assembly in the left atriumafter partial emergence from the valve assembly delivery sheath of FIG.15. The valve assembly is configured in a first (partially expanded)arrangement.

FIG. 17 shows a perspective view of the valve assembly of FIG. 16 withthe valve deployment system being manipulated in preparation for theinstallation of the valve assembly into the anchor assembly.

FIG. 18 shows a perspective view of the valve assembly of FIG. 17 (whilestill in the first (partially expanded) arrangement) being positionedwithin the anchor assembly.

FIG. 19 shows a perspective view of the valve assembly of FIG. 18, withthe valve assembly expanded within the anchor assembly and detached fromthe deployment system, but prior to deployment of the SAM containmentmember.

FIG. 20 shows a side view of the anchor assembly of FIG. 9 with a SAMcontainment member coupled with an example deployment system in apre-deployed configuration, in accordance with some embodiments.

FIG. 21 shows the anchor assembly of FIG. 20 with the SAM containmentmember in a deployed configuration, in accordance with some embodiments.

FIG. 22 shows a schematic side view of a native mitral valve coupledwith the anchor assembly of FIG. 9, and the deployment system of FIG.20, with the SAM containment member in a first partially-deployedconfiguration, in accordance with some embodiments.

FIG. 23 shows another schematic side view of the native mitral valvecoupled with the anchor assembly as in FIG. 22, and the deploymentsystem of FIG. 20, with the SAM containment member in a secondpartially-deployed configuration, in accordance with some embodiments.

FIG. 24 shows another schematic side view of the native mitral valvecoupled with the anchor assembly as in FIGS. 22 and 23, with the SAMcontainment member in a deployed configuration, in accordance with someembodiments.

FIG. 25 shows a side view of the anchor assembly of FIG. 9 with a SAMcontainment member coupled with another example deployment system in apre-deployed configuration, in accordance with some embodiments.

FIG. 26 shows the anchor assembly of FIG. 25 with the SAM containmentmember in a deployed configuration while still coupled with thedeployment system, in accordance with some embodiments.

FIG. 27 shows a side view of the anchor assembly of FIG. 11 with a SAMcontainment member coupled with another example deployment system in apre-deployed configuration, in accordance with some embodiments.

FIG. 28 shows the anchor assembly of FIG. 27 with the SAM containmentmember in a deployed configuration, in accordance with some embodiments.

FIG. 29 shows a schematic side view of a native mitral valve coupledwith the anchor assembly of FIG. 11, and the deployment system of FIG.27, with the SAM containment member in a pre-deployed configuration, inaccordance with some embodiments.

FIG. 30 shows an anterior side view of the anchor assembly of FIG. 11and the deployment system of FIG. 27 with the SAM containment member ina pre-deployed configuration as in FIG. 29, in accordance with someembodiments.

FIG. 31 shows another schematic side view of the native mitral valvecoupled with the anchor assembly as in FIG. 29, and the deploymentsystem of FIG. 27, with the SAM containment member in apartially-deployed configuration, in accordance with some embodiments.

FIG. 32 shows a front view of the anchor assembly of FIG. 11 and thedeployment system of FIG. 27 with the SAM containment member in apartially-deployed configuration as in FIG. 31, in accordance with someembodiments.

FIG. 33 shows another schematic side view of the native mitral valvecoupled with the anchor assembly as in FIG. 29, and the deploymentsystem of FIG. 27, with the SAM containment member in apartially-deployed configuration, in accordance with some embodiments.

FIG. 34 shows another schematic side view of the native mitral valvecoupled with the anchor assembly as in FIG. 29, with the SAM containmentmember in a fully deployed configuration, in accordance with someembodiments.

FIG. 35 shows an anterior side view of a valve frame of a valve assemblyof FIGS. 16-19, in accordance with some embodiments.

FIG. 36 shows a bottom view of the valve frame of FIG. 35.

FIG. 37 is an exploded posterior side view of an anchor assembly andvalve assembly of FIGS. 16-19, in accordance with some embodiments.

FIG. 38 is a top view of an example prosthetic mitral valve system thatincludes a valve assembly engaged with an anchor assembly, in accordancewith some embodiments.

FIG. 39 is a bottom view of the example prosthetic mitral valve systemof FIG. 38.

FIG. 40 shows a top view of the prosthetic mitral valve system of FIG.38 implanted within a native mitral valve. The occluder portion ofprosthetic mitral valve system is shown in a closed state.

FIG. 41 shows a top view of the prosthetic mitral valve system of FIG.38 implanted within a native mitral valve. The occluder portion of theprosthetic mitral valve system is shown in an open state.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

This disclosure describes embodiments of a prosthetic heart valvesystem, such as prosthetic mitral valve systems, and transcathetersystems and methods for implanting prosthetic heart valve systems. Insome embodiments, the prosthetic mitral valve system can be deployed tointerface and anchor in cooperation with the native anatomicalstructures of a mitral valve (and, optionally, in a manner that permitsthe continued natural function of the chordae tendineae of the nativemitral valve leaflets even after the anchor component is deployed). Asdescribed in more detail below, FIGS. 1-7 and 15-34 describe atranscatheter mitral valve delivery system and method by which theprosthetic mitral valve system can be deployed to interface and anchorin cooperation with the anatomical structures of a native mitral valve.Also, in FIGS. 9-12 and 20-34, multiple embodiments of prosthetic mitralvalve SAM containment members are described by which the prostheticvalves prevent a native anterior leaflet from “flopping” or being drawnoutward into the LVOT to create an obstruction of the LVOT.

Referring to FIG. 1, an example transcatheter mitral valve deliverysystem 100 can be navigated through a patient's vasculature to obtainaccess to the patient's heart 10. The transcatheter delivery system 100facilitates implantation of a prosthetic mitral valve in a beating heart10 using a percutaneous, vessel cutdown, or minimally invasive technique(without open-chest surgery). In some implementations, the transcatheterdelivery system 100 is used in conjunction with one or more imagingmodalities such as x-ray fluoroscopy, echocardiography, magneticresonance imaging, computed tomography (CT), and the like.

The heart 10 (depicted in cross-section from a posterior perspective)includes a right atrium 12, a right ventricle 14, a left atrium 16, anda left ventricle 18. A tricuspid valve 13 separates the right atrium 12from the right ventricle 14. A mitral valve 17 separates the left atrium16 from the left ventricle 18. An atrial septum 15 separates the rightatrium 12 from the left atrium 16. An inferior vena cava 11 is confluentwith the right atrium 12. It should be understood that this depiction ofthe heart 10 is somewhat stylized. The same is true for FIGS. 2-4. FIGS.1-4 provide general depictions of the approach to the mitral valve 17that is used in some implementations. But, the commissuralcross-sectional views of FIG. 5 and thereafter more accurately depictthe orientation of the prosthetic mitral valves in relation to the heart10.

In the depicted embodiment, the delivery system 100 includes a guidewire110, a primary deflectable catheter 120, and an anchor delivery sheath130. Additional components of the delivery system 100 will be describedfurther below. The anchor delivery sheath 130 is slidably (androtationally) disposed within a lumen of the primary deflectablecatheter 120. The guidewire 110 is slidably disposed within a lumen ofthe anchor delivery sheath 130. In this depiction, the anchor deliverysheath 130 has been partially extended relative to the primarydeflectable catheter 120, allowing a flared portion 132 to expandoutward, as described further below.

In the depicted implementation, the guidewire 110 is installed into theheart 10 prior to the other components of the delivery system 100. Insome embodiments, the guidewire 110 has a diameter of about 0.035 inches(about 0.89 mm). In some embodiments, the guidewire 110 has a diameterin a range of about 0.032 inches to about 0.038 inches (about 0.8 mm toabout 0.97 mm). In some embodiments, the guidewire 110 has a diametersmaller than 0.032 inches (about 0.80 mm) or larger than 0.038 inches(about 0.97 mm). In some embodiments, the guidewire 110 is made ofmaterials such as, but not limited to, nitinol, stainless steel,high-tensile-strength stainless steel, and the like, and combinationsthereof. The guidewire 110 may include various tip designs (e.g., J-tip,straight tip, etc.), tapers, coatings, covers, radiopaque (RO) markers,and other features. In some embodiments, the guidewire 110 has one ormore portions with differing lateral stiffnesses, column strengths,lubricity, and/or other physical properties in comparison to otherportions of the guidewire 110.

In some implementations, the guidewire 110 is percutaneously insertedinto a femoral vein of the patient. The guidewire 110 is routed to theinferior vena cava 11 and into the right atrium 12. After creating anopening in the atrial septum 15 (e.g., a trans-septal puncture of thefossa ovalis), the guidewire 110 is routed into the left atrium 16.Lastly, the guidewire 110 is routed through the mitral valve 17 and intothe left ventricle 18. In some implementations, the guidewire 110 can beinstalled into the heart 10 along other anatomical pathways. Theguidewire 110 thereafter serves as a rail over which other components ofthe delivery system 100 are passed.

In the depicted implementation, the primary deflectable catheter 120 isinstalled by pushing it over the guidewire 110. In some implementations,a dilator tip is used in conjunction with the primary deflectablecatheter 120 as the primary deflectable catheter 120 is advanced overthe guidewire 110. Alternatively, a balloon catheter could be used asthe initial dilation means. After the distal end of the primarydeflectable catheter 120 reaches the left atrium 16, the dilator tip canbe withdrawn. In some embodiments, the distal end portion of the primarydeflectable catheter 120 is steerable. Using steering, the distal endportion of the primary deflectable catheter 120 can be oriented asdesired in order to navigate the patient's anatomy. For example, theprimary deflectable catheter 120 can be angled within the right atrium12 to navigate the primary deflectable catheter 120 from the inferiorvena cava 11 to the atrial septum 15.

In some embodiments, the primary deflectable catheter 120 has an outerdiameter of about 28 Fr (about 9.3 mm), or about 30 Fr (about 10.0 mm).In some embodiments, the primary deflectable catheter 120 has an outerdiameter in the range of about 26 Fr to about 34 Fr (about 8.7 mm toabout 11.3 mm). In some embodiments, the primary deflectable catheter120 has an outer diameter in the range of about 20 Fr to about 28 Fr(about 6.7 mm to about 9.3 mm).

The primary deflectable catheter 120 can comprise a tubular polymeric ormetallic material. For example, in some embodiments the primarydeflectable catheter 120 can be made from polymeric materials such as,but not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylenepropylene (FEP), HYTREL®, nylon, PICOFLEX®, PEBAX®, TECOFLEX®, and thelike, and combinations thereof. In alternative embodiments, the primarydeflectable catheter 120 can be made from metallic materials such as,but not limited to, nitinol, stainless steel, stainless steel alloys,titanium, titanium alloys, and the like, and combinations thereof. Insome embodiments, the primary deflectable catheter 120 can be made fromcombinations of such polymeric and metallic materials (e.g., polymerlayers with metal braid, coil reinforcement, stiffening members, and thelike, and combinations thereof). In some embodiments, the primarydeflectable catheter 120 can comprise a slotted tube.

The example delivery system 100 also includes the anchor delivery sheath130. In some implementations, after the primary deflectable catheter 120is positioned with its distal end in the left atrium 16, the anchordelivery sheath 130 is installed into a lumen of the primary deflectablecatheter 120 (over the guidewire 110) and advanced through the primarydeflectable catheter 120. As described further below, in someembodiments the anchor delivery sheath 130 is preloaded with aprosthetic valve anchor assembly and other components of the deliverysystem 100.

In some embodiments, the anchor delivery sheath 130 can be made from thematerials described above in reference to the primary deflectablecatheter 120. In some embodiments, the anchor delivery sheath 130 has anouter diameter in the range of about 20 Fr to about 28 Fr (about 6.7 mmto about 9.3 mm). In some embodiments, the anchor delivery sheath 130has an outer diameter in the range of about 14 Fr to about 24 Fr (about4.7 mm to about 8.0 mm).

In the depicted embodiment, the anchor delivery sheath 130 includes aflared distal end portion 132. In some embodiments, no such flareddistal end portion 132 is included. The flared distal end portion 132can collapse to a lower profile when constrained within the primarydeflectable catheter 120. When the flared distal end portion 132 isexpressed from the primary deflectable catheter 120, the flared distalend portion 132 can self-expand to the flared shape. In someembodiments, the material of the flared distal end portion 132 includespleats or folds, may be a continuous flared end or may be separated intosections such as flower petals, and may include one or more resilientelements that bias the flared distal end portion 132 to assume theflared configuration in the absence of restraining forces (such as fromcontainment within the primary deflectable catheter 120). The flareddistal end portion 132 can be advantageous, for example, for recapturingthe anchor assembly within the lumen of the anchor delivery sheath 130after the anchor assembly has been expressed from the flared distal endportion 132.

In some embodiments, the maximum outer diameter of the flared distal endportion 132 is in a range of about 30 Fr to about 34 Fr (about 10.0 mmto about 11.3 mm). In some embodiments, the maximum outer diameter ofthe flared distal end portion 132 is in a range of about 32 Fr to about44 Fr (about 10.7 mm to about 14.7 mm). In some embodiments, the maximumouter diameter of the flared distal end portion 132 is in a range ofabout 24 Fr to about 30 Fr (about 8.0 mm to about 10.0 mm). In someembodiments, the maximum outer diameter of the flared distal end portion132 is less than about 24 Fr (about 8.0 mm) or greater than about 44 Fr(about 14.7 mm).

Referring to FIG. 2, additional components of the example deliverysystem 100 can include a proximal control sheath 140, a secondarydeflectable catheter 150, and a distal pusher catheter 160. The proximalcontrol sheath 140 is slidably disposed within a lumen of the anchordelivery sheath 130. The secondary deflectable catheter 150 is slidablydisposed within a lumen of the proximal control sheath 140. The distalpusher catheter 160 is slidably disposed within a lumen of the secondarydeflectable catheter 150. These components of the delivery system 100can be manipulated by a clinician operator to control the position andorientation of an anchor assembly 200. The anchor assembly 200 isslidably disposed over the guidewire 110.

In some implementations of delivery system 100, one or more of theproximal control sheath 140, the secondary deflectable catheter 150, thedistal pusher catheter 160, and the anchor assembly 200 have been loadedinto the anchor delivery sheath 130 prior to the advancement of theanchor delivery sheath 130 into the primary deflectable catheter 120 asshown in FIG. 1. That is, in some cases the proximal control sheath 140,the secondary deflectable catheter 150, the distal pusher catheter 160,and/or the anchor assembly 200 are already installed in the anchordelivery sheath 130 as the anchor delivery sheath 130 is distallyadvanced into the primary deflectable catheter 120 to attain thearrangement shown in FIG. 1. In other implementations, one or more ofthe proximal control sheath 140, the secondary deflectable catheter 150,the distal pusher catheter 160, and the anchor assembly 200 are distallyadvanced into the anchor delivery sheath 130 after the anchor deliverysheath 130 has been advanced into the primary deflectable catheter 120to attain the arrangement shown in FIG. 1.

The distal pusher catheter 160 is releasably coupled with a hub 210 ofthe anchor assembly 200. A proximal end of the anchor assembly 200 isalso releasably coupled to the proximal control sheath 140 by one ormore control wires 142. While the depicted embodiment includes onecontrol wire 142, in some embodiments two, three, four, five, or morethan five control wires are included.

In some embodiments, the position of the anchor assembly 200 can becontrolled by manipulating the positions of the distal pusher catheter160 and/or the proximal control sheath 140. For example, in the depictedembodiment the anchor assembly 200 can be expressed out from the anchordelivery sheath 130 (as shown in FIG. 2) by moving the distal pushercatheter 160 and/or the proximal control sheath 140 distally in relationto the anchor delivery sheath 130. In some implementations, theexpression of the anchor assembly 200 is caused by proximally pullingback the anchor delivery sheath 130 while generally maintaining thepositions of the distal pusher catheter 160 and/or the proximal controlsheath 140. In some implementations, the expression of the anchorassembly 200 is caused by a combination of proximally pulling back theanchor delivery sheath 130 while distally extending the positions of thedistal pusher catheter 160 and/or the proximal control sheath 140.

As the anchor assembly 200 emerges from the confines of the anchordelivery sheath 130, the anchor assembly 200 expands from a low-profiledelivery configuration to a partially expanded configuration (as shownin FIG. 2). The extent of expansion of the anchor assembly 200 can be atleast partially controlled by the relative positioning of the proximalcontrol sheath 140 in relation to the distal pusher catheter 160. Forinstance, as the proximal control sheath 140 is moved proximally inrelation to the distal pusher catheter 160, the anchor assembly 200 isaxially elongated and radially contracted. Conversely, as the proximalcontrol sheath 140 is moved distally in relation to the distal pushercatheter 160, the anchor assembly 200 is axially shortened and radiallyexpanded. In some implementations, this control of the radial size ofthe anchor assembly 200 is used by a clinician during the process ofdeploying the anchor assembly 200 within the native mitral valve 17, asdescribed further below. As described further below, the control wire142 can also be used to control some radial expansion of the anchorassembly 300 (without changing the relative distance of the proximalcontrol sheath 140 in relation to the distal pusher catheter 160).

It should be understood that the prosthetic mitral valves providedherein are comprised of an anchor assembly 200 and a separable valveassembly (e.g., refer to FIG. 37). The anchor assembly 200 is deployedto an arrangement interfacing within the native mitral valve 17 prior todeployment of the valve assembly. Said differently, after implanting theanchor assembly 200 within the native mitral valve 17, the valveassembly can then be deployed within the anchor assembly 200 and withinthe native mitral valve 17 (as described further below). Therefore, itcan be said that the prosthetic mitral valves provided herein aredeployed using a staged implantation method. That is, the anchorassembly 200 is deployed in one stage, and the valve assembly isdeployed in a subsequent stage. In some embodiments, as describedfurther below, a SAM containment member is deployed as part of thedeployment method. In some implementations, the deployment of the valveassembly takes place right after the deployment of the anchor assembly200 (e.g., during the same medical procedure). In some implementations,the deployment of the valve assembly takes place hours, days, weeks, oreven months after the deployment of the anchor assembly 200 (e.g.,during a subsequent medical procedure).

The staged implantation method of the prosthetic mitral valves providedherein is facilitated by the fact that when the anchor assembly 200itself is implanted within the native mitral valve 17, the native mitralvalve 17 continues to function essentially as before the implantation ofthe anchor assembly 200 without a significant impact on cardiovascularphysiology. That is the case because, as described further below, theanchor assembly 200 interfaces and anchors within structural aspects ofthe native mitral valve 17 without substantially interfering with theleaflets or chordae tendineae of the native mitral valve 17.

Still referring to FIG. 2, in the depicted arrangement the distal endportion of the secondary deflectable catheter 150 is located at leastpartially internally within the anchor assembly 200. The secondarydeflectable catheter 150 can be manipulated by a clinician operator toreversibly bend the distal end portion of the secondary deflectablecatheter 150. As the secondary deflectable catheter 150 is bent by theclinician, other components of the delivery system 100 may bend alongwith the secondary deflectable catheter 150. For example, one or more ofthe distal pusher 160 and the proximal control sheath 140 may bend inresponse to the bending of the deflectable catheter 150. Because theanchor assembly 200 is coupled to the distal pusher 160 and the proximalcontrol sheath 140, the anchor assembly 200 can, in turn, be rotated bybending the secondary deflectable catheter 150.

Referring to FIG. 3, as described above, the secondary deflectablecatheter 150 can be articulated (also referred to as steered, deflected,bent, curved, etc.) to pivot laterally (pan, rotate, etc.) the anchorassembly 200 while the anchor assembly 200 is within the left atrium 16.Such rotation of the anchor assembly 200 is advantageous, for example,to orient the anchor assembly 200 in a desired relationship to thenative mitral valve 17 in preparation for implanting the anchor assembly200 within the native mitral valve 17. In some implementations, it isdesirable to orient the anchor assembly 200 so that its longitudinalaxis is generally perpendicular to the native mitral valve 17. Thelateral pivoting of the partially or fully expanded anchor assembly 200within the atrium 16 may be advantageous versus having to pivotlaterally the anchor assembly 200 while it is still constrained within adelivery sheath, as the latter assembly is a relatively large and stiffcatheter assembly.

In preparation for engaging the anchor assembly 200 with the nativemitral valve 17, the clinician operator may manipulate the radial sizeof the anchor frame 200 so that the anchor frame 200 can be passedthrough the native mitral valve 17 without damaging the native mitralvalve 17. For example, the clinician can move the proximal controlsheath 140 proximally in relation to the distal pusher catheter 160 toradially contract the anchor assembly 200. With the anchor assembly 200radially contracted, the anchor frame 200 can be safely passed throughthe native mitral valve 17 without damaging the native mitral valve 17.

Referring to FIG. 4, while the secondary deflectable catheter 150 isretained in its bent configuration as described in reference to FIG. 3,the distal pusher catheter 160 and the proximal control sheath 140 canbe simultaneously advanced. Because the distal pusher catheter 160 isreleasably coupled to the hub 210 of the anchor assembly 200, andbecause the proximal control sheath 140 is releasably coupled to theproximal end of the anchor assembly 200 via the one or more wires 142 aand 142 b, generally simultaneous advancement of the distal pushercatheter 160 and the proximal control sheath 140 results in advancementof the anchor assembly 200. The anchor assembly 200 is advanced suchthat the distal end of anchor assembly 200 is within the left ventricle18 while the proximal end of the anchor assembly 200 is within the leftatrium 16. Hence, some portions of the anchor assembly 200 are on eachside of the native mitral valve 17.

In the depicted embodiment, the anchor assembly 200 includes four anchorfeet: a lateral anterior foot 220 a, a lateral posterior foot 220 b, amedial posterior foot 220 c, and a medial anterior foot 220 d. In someembodiments, fewer or more anchor feet may be included (e.g., two,three, five, six, or more than six). In some embodiments, the anchorfeet 220 a, 220 b, 220 c, and 220 d are portions of the anchor assembly200 that are configured for contact with a sub-annular gutter 19 of thenative mitral valve 17, without penetrating tissue of the native mitralvalve 17. Accordingly, the anchor feet 220 a, 220 b, 220 c, and 220 dhave atraumatic surfaces that are generally comparable to feet. However,in some embodiments one or more of the anchor feet 220 a, 220 b, 220 c,and 220 d are configured to penetrate tissue and may have anchorfeatures such as barbs, coils, hooks, and the like.

In the arrangement of FIG. 4, the anchor feet 220 a, 220 b, 220 c, and220 d are positioned below the sub-annular gutter 19. In thisarrangement, the radial size of the anchor assembly 200 can be increasedto align the anchor feet 220 a, 220 b, 220 c, and 220 d with thesub-annular gutter 19. For example, the clinician can move the proximalcontrol sheath 140 distally in relation to the distal pusher catheter160 to radially expand the anchor assembly 200 to align the anchor feet220 a, 220 b, 220 c, and 220 d with the sub-annular gutter 19. Suchalignment can be performed in preparation for seating the anchor feet220 a, 220 b, 220 c, and 220 d within the sub-annular gutter 19.

Referring to FIG. 5, a commissural cross-sectional view of the heart 10provides another perspective of the anchor assembly 200 in the samearrangement in relation to the native mitral valve 17 as shown in FIG.4. This commissural cross-sectional view of the heart 10 is across-sectional view taken through the mitral valve 17 along a planethrough the left atrium 16 and left ventricle 18 that is parallel to theline that intersects the two commissures of the mitral valve 17 (asdescribed further in reference to FIG. 8 below). In the following FIGS.5-7 and 13-17, the commissural cross-sectional view of the heart 10 willbe used to describe the delivery system 100 and methods for deployingthe prosthetic mitral valves provided herein. The view in FIGS. 5-7 and13-17 is slightly tilted so that better visualization of the anchorassembly 200 is provided.

The anchor feet 220 a, 220 b, 220 c, and 220 d are positioned below thesub-annular gutter 19. In this position, the anchor feet 220 a, 220 b,220 c, and 220 d are positioned under the systolic and diastolicexcursions of the leaflets of the native mitral valve 17. In thisorientation, the anchor feet 220 a, 220 b, 220 c, and 220 d can bealigned with the sub-annular gutter 19 in preparation for seating theanchor feet 220 a, 220 b, 220 c, and 220 d within the sub-annular gutter19.

In this figure, portions of an example SAM containment member 212 are inview. In the depicted embodiment, the SAM containment member 212 extendsfrom the anchor assembly 200. For example, the SAM containment member212 comprises an elongate member with a first end that extends from afirst portion of the anchor assembly 200 and a second end that extendsfrom a second portion of the anchor assembly 200. In particularembodiments, the SAM containment member 212 is integrally formed as partof the anchor assembly 200. In specific embodiments, the SAM containmentmember 212, or portions thereof, may be formed separately from theanchor assembly 200 and thereafter attached to the anchor assembly 200.

The SAM containment member 212 can be arranged in a pre-deployedconfiguration as shown. As described further below, the SAM containmentmember 212 can be reconfigured to a deployed configuration such that theSAM containment member 212 physically prevents an anterior leaflet of anative mitral valve from obstructing the LVOT. In some embodiments, theSAM containment member 212 is biased to self-reconfigure to the deployedconfiguration when the SAM containment member 212 is unconstrained.While one particular embodiment of the SAM containment member 212 isdepicted, it should be understood that multiple SAM containment memberembodiments are envisioned and within the scope of this disclosure.

Referring to FIG. 6, the distal pusher 160 and the proximal controlsheath 140 can be simultaneously retracted in relation to the secondarydeflectable catheter 150 and the primary deflectable catheter 120. As aresult, the anchor feet 220 a, 220 b, 220 c, and 220 d become seated inthe sub-annular gutter 19. In this position, the anchor feet 220 a, 220b, 220 c, and 220 d are positioned under the systolic and diastolicexcursions of the leaflets of the native mitral valve 17, and the otherstructures of the anchor assembly 200 do not inhibit the movements ofthe leaflets. Therefore, with the anchor assembly 200 coupled to thestructures of the mitral valve 17 as described, the mitral valve 17 cancontinue to function as it did before the placement of the anchorassembly 200. In addition, the manner in which the anchor assembly 200interfaces with the native mitral valve 17 does not result indeformation of the native mitral valve 17. With the SAM containmentmember 212 in its pre-deployed configuration, the SAM containment member212 does not affect the natural function of the native mitral valve 17.Therefore, the native mitral valve 17 can continue to function as it didbefore the placement of the anchor assembly 200.

Referring to FIG. 7, with the anchor assembly 200 engaged within thenative mitral valve 17, components of the delivery system 100 can bewithdrawn from the anchor assembly 200. For example, the control wire142 can be detached from the proximal end of the anchor assembly 200.Thereafter, the proximal control sheath 140 can be withdrawn. Thesecondary deflectable catheter 150 can also be withdrawn. In fact, if sodesired, the proximal control sheath 140, the secondary deflectablecatheter 150, and the anchor delivery sheath 130 can be completelywithdrawn from the primary deflectable catheter 120. In contrast, insome implementations the distal pusher catheter 160 is advantageouslyleft attached to the hub 210 of the anchor assembly 200 (and leftattached to the SAM containment member 212 in some implementations). Aswill be described further below, in some implementations the distalpusher catheter 160 can be used as a rail on which a valve assembly isdeployed into the interior of the anchor assembly 200. However, in someimplementations the anchor assembly 200 is completely detached from thedelivery system 100, and the delivery system 100 is removed from thepatient. After a period of minutes, hours, days, weeks, or months,subsequent to the deployment of the anchor assembly 200, a valveassembly can be installed into the anchor assembly 200 to complete theinstallation of the prosthetic mitral valve.

In the depicted implementation, the SAM containment member 212 is stillrestrained in its pre-deployed configuration. As described furtherbelow, in some embodiments the depicted embodiment of the SAMcontainment member 212 is deployed after the installation of a valveassembly into the anchor assembly 200. Alternatively, as describedfurther below, in some embodiments of the SAM containment member 212,the SAM containment member 212 is deployed prior to the installation ofa valve assembly into the anchor assembly 200.

Referring to FIG. 8, the anatomy of the native mitral valve 17 includessome consistent and predictable structural features across patients thatcan be utilized for engaging the anchor assembly 200 therewith. Forexample, the native mitral valve 17 includes the aforementionedsub-annular gutter 19. In addition, the native mitral valve 17 includesa D-shaped annulus 28, an anterolateral commissure 30 a, a posteromedialcommissure 30 b, a left fibrous trigone 134 a, and a right fibroustrigone 134 b. Further, the native mitral valve 17 includes an anteriorleaflet 20 and a three-part posterior leaflet 22. The posterior leaflet22 includes a lateral scallop 24 a, a middle scallop 24 b, and a medialscallop 24 c. The free edges of the posterior leaflet 22 and theanterior leaflet 20 meet along a coaptation line 32.

The D-shaped annulus 28 defines the structure from which the anteriorleaflet 20 and posterior leaflet 22 extend and articulate. The left andright fibrous trigones 134 a and 134 b are located near the left andright ends of the anterior leaflet 20 and generally adjacent the lateraland medial scallops 24 a and 24 c of the posterior leaflet 22. Thesub-annular gutter 19 runs along the annulus 28 between the left andright fibrous trigones 134 a and 134 b along the posterior leaflet 22.

The regions at or near the high collagen annular trigones 134 a and 134b can generally be relied upon to provide strong, stable anchoringlocations. The muscle tissue in the regions at or near the trigones 134a and 134 b also provides a good tissue ingrowth substrate for addedstability and migration resistance of the anchor assembly 200.Therefore, the regions at or near the trigones 134 a and 134 b define aleft anterior anchor zone 34 a and a right anterior anchor zone 34 brespectively. The left anterior anchor zone 34 a and the right anterioranchor zone 34 b provide advantageous target locations for placement ofthe lateral anterior foot 220 a and the medial anterior foot 220 drespectively.

Referring also to FIG. 9, the depicted embodiment of the anchor assembly200 also includes the lateral posterior foot 220 b and the medialposterior foot 220 c. As previously described, the lateral posteriorfoot 220 b and the medial posterior foot 220 c can also beadvantageously positioned in the sub-annular gutter 19 in order toprovide balanced and atraumatic coupling of the anchor assembly 200 tothe native mitral valve 17. Therefore, a left posterior anchor zone 34 band a right anterior anchor zone 34 c are defined in the sub-annulargutter 19. The left posterior anchor zone 34 b and the right anterioranchor zone 34 c can receive the lateral posterior foot 220 b and themedial posterior foot 220 c respectively. In some implementations, thelocations of the left posterior anchor zone 34 b and the right anterioranchor zone 34 c may vary from the depicted locations while stillremaining within the sub-annular gutter 19. It should be understood thatthe depicted anchor assembly 200 is merely one non-limiting example ofthe anchor assemblies provided within the scope of this disclosure.

In some embodiments, the anchor assembly 200 includes supra-annularstructures and sub-annular structures. For example, the sub-annularstructures of the anchor assembly 200 include the aforementioned anchorfeet 220 a, 220 b, 220 c, and 220 d, the SAM containment member 212, andthe hub 210. In some embodiments, as described above, the hub 210functions as a connection structure for the delivery system 100 (e.g.,refer to FIG. 2). In addition, the hub 210 can function as a stabilizingstructural component from which a lateral anterior sub-annular supportarm 230 a, a lateral posterior sub-annular support arm 230 b, a medialposterior sub-annular support arm 230 c, and a medial anteriorsub-annular support arm 230 d extend to the anchor feet 220 a, 220 b,220 c, and 220 d respectively.

In the depicted embodiment, the SAM containment member 212 includes alateral anterior arm 213 a and a medial anterior arm 213 d. The lateralanterior arm 213 a extends from the lateral anterior sub-annular supportarm 230 a. The medial anterior arm 213 d extends from the medialanterior sub-annular support arm 230 d. In some embodiments, portions ofthe SAM containment member 212 may extend from other areas on the anchorassembly 200.

In some embodiments, such as the depicted embodiment, the supra-annularstructures of the anchor assembly 200 include: a lateral anterior atrialholding feature 240 a, a lateral posterior atrial holding feature 240 b,a medial posterior atrial holding feature 240 c, and a medial anterioratrial holding feature 240 d; an anterior anchor arch 250 a, a leftanchor arch 250 b, a posterior anchor arch 250 c, and a right anchorarch 250 d; and connection bridges 260. The anterior anchor arch 250 a,left anchor arch 250 b, posterior anchor arch 250 c, and right anchorarch 250 d are joined with each other to form an undulatingsupra-annular ring 250 that acts as a supra-annular structural elementfor the anchor assembly 200. As will be described further below, thesupra-annular ring 250 also defines an opening to a space within theinterior of the anchor assembly 200 that is configured to receive andengage with a valve assembly. The atrial holding features 240 a, 240 b,240 c, and 240 d are configured to contact the shelf-like supra-annulartissue surface above the mitral valve annulus, and to thereby stabilizethe anchor assembly 200 in supra-annular areas that are generallyopposite of the anchor feet 220 a, 220 b, 220 c, and 220 d respectively.

In some embodiments, connection bridges 260 provide enhanced stabilityand fatigue resistance from vertically oriented forces on a companionartificial valve assembly when the valve (not shown) is closed andblocking pressurized blood during systole. The anchor assembly 200 canalso include one or more eyelets 226 in frame portions adjacent thearches, which are additional control points for delivery and retrievalof the assembly, or could be used to secure a positional delivery frame.

In some embodiments, such as the depicted embodiment, the supra-annularstructures and sub-annular structures of the anchor assembly 200 areinterconnected by a lateral anterior inter-annular connection 270 a, alateral posterior inter-annular connection 270 b, a medial posteriorinter-annular connection 270 c, and a medial anterior inter-annularconnection 270 d. For example, the lateral anterior inter-annularconnection 270 a connects the lateral anterior anchor foot 220 a withthe lateral anterior atrial holding feature 240 a. In addition, thelateral anterior inter-annular connection 270 a connects the lateralanterior anchor foot 220 a with the anterior anchor arch 250 a and theleft anchor arch 250 b. In the depicted embodiment, each of the otherinter-annular connections 270 b, 270 c, and 270 d interconnect portionsof the supra-annular structures and sub-annular structures in mannersanalogous to that of the lateral anterior inter-annular connection 270a. For example, the lateral anterior inter-annular connection 270 bconnects the lateral anterior anchor foot 220 b with the left anchorarch 250 b and the posterior anchor arch 250 c; the lateral anteriorinter-annular connection 270 c connects the lateral anterior anchor foot220 c with the posterior anchor arch 250 c and the right anchor arch 250d; and the lateral anterior inter-annular connection 270 d connects thelateral anterior anchor foot 220 d with the right anchor arch 250 d andthe anterior anchor arch 250 a.

In some embodiments, the elongate members of the anchor assembly 200,including SAM containment member 212, are formed from a single piece ofprecursor material (e.g., sheet or tube) that is cut, expanded, andconnected to the hub 210. For example, some embodiments are fabricatedfrom a tube that is laser-cut (or machined, chemically etched, water-jetcut, etc.) and then expanded and heat-set into its final expanded sizeand shape. In some embodiments, the anchor assembly 200, including SAMcontainment member 212, is created compositely from multiple elongatemembers (e.g., wires or cut members) that are joined together with thehub 210 and each other to form the anchor assembly 200.

The elongate members of the anchor assembly 200 can be comprised ofvarious materials and combinations of materials. In some embodiments,nitinol (NiTi) is used as the material of the elongate members of theanchor assembly 200, but other materials such as stainless steel, L605steel, polymers, MP35N steel, stainless steels, titanium,colbalt/chromium alloy, polymeric materials, Pyhnox, Elgiloy, or anyother appropriate biocompatible material, and combinations thereof canbe used. The super-elastic properties of NiTi make it a particularlygood candidate material for the elongate members of the anchor assembly200 because, for example, NiTi can be heat-set into a desired shape.That is, NiTi can be heat-set so that the anchor assembly 200 tends toself-expand into a desired shape when the anchor assembly 200 isunconstrained, such as when the anchor assembly 200 is deployed out fromthe anchor delivery sheath 130. A anchor assembly 200 made of NiTi, forexample, may have a spring nature that allows the anchor assembly 200 tobe elastically collapsed or “crushed” to a low-profile deliveryconfiguration and then to reconfigure to the expanded configuration asshown in FIG. 9. The anchor assembly 200 may be generally conformable,fatigue resistant, and elastic such that the anchor assembly 200 canconform to the topography of the surrounding tissue when the anchorassembly 200 is deployed in a native mitral valve of a patient.

In some embodiments, the diameter or width/thickness of one or more ofthe elongate members forming the anchor assembly 200 may be within arange of about 0.008″ to about 0.015″ (about 0.20 mm to about 0.40 mm),or about 0.009″ to about 0.030″ (about 0.23 mm to about 0.76 mm), orabout 0.01″ to about 0.06″ (about 0.25 mm to about 1.52 mm), or about0.02″ to about 0.10″ (about 0.51 mm to about 2.54 mm), or about 0.06″ toabout 0.20″ (about 1.52 mm to about 5.08 mm). In some embodiments, theelongate members forming the anchor assembly 200 may have smaller orlarger diameters or widths/thicknesses. In some embodiments, each of theelongate members forming the anchor assembly 200 has essentially thesame diameter or width/thickness. In some embodiments, one or more ofthe elongate members forming the anchor assembly 200 has a differentdiameter or width/thickness than one or more of the other elongatemembers of the anchor assembly 200. In some embodiments, one or moreportions of one or more of the elongate members forming the anchorassembly 200 may be tapered, widened, narrowed, curved, radiused, wavy,spiraled, angled, and/or otherwise non-linear and/or not consistentalong the entire length of the elongate members of the anchor assembly200. Such features and techniques can also be incorporated with thevalve assemblies of the prosthetic mitral valves provided herein.

In some embodiments, the elongate members forming the anchor assembly200 may vary in diameter, thickness and/or width so as to facilitatevariations in the forces that are exerted by the anchor assembly 200 inspecific regions thereof, to increase or decrease the flexibility of theanchor assembly 200 in certain regions, to enhance migration resistance,and/or to control the process of compression (crushability) inpreparation for deployment and the process of expansion duringdeployment of the anchor assembly 200.

In some embodiments, one or more of the elongate members of the elongatemembers forming the anchor assembly 200 may have a circularcross-section. In some embodiments, one or more of the elongate membersforming the anchor assembly 200 may have a rectangular cross-sectionalshape, or another cross-sectional shape that is not rectangular.Examples of cross-sectional shapes that the elongate members forming theanchor assembly 200 may have include circular, C-shaped, square, ovular,rectangular, elliptical, triangular, D-shaped, trapezoidal, includingirregular cross-sectional shapes formed by a braided or strandedconstruct, and the like. In some embodiments, one or more of theelongate members forming the anchor assembly 200 may be essentially flat(i.e., such that the width to thickness ratio is about 2:1, about 3:1,about 4:1, about 5:1, or greater than about 5:1). In some examples, oneor more of the elongate members forming the anchor assembly 200 may beformed using a center-less grind technique, such that the diameter ofthe elongate members varies along the length of the elongate members.

The anchor assembly 200 may include features that are directed toenhancing one or more desirable functional performance characteristicsof the prosthetic mitral valve devices. For example, some features ofthe anchor assembly 200 may be directed to enhancing the conformabilityof the prosthetic mitral valve devices. Such features may facilitateimproved performance of the prosthetic mitral valve devices by allowingthe devices to conform to irregular tissue topographies and/ordynamically variable tissue topographies, for example. Suchconformability characteristics can be advantageous for providingeffective and durable performance of the prosthetic mitral valvedevices. In some embodiments of the anchor assembly 200, some portionsof the anchor assembly 200 are designed to be more conformable thanother portions of the same anchor assembly 200. That is, theconformability of a single anchor assembly 200 can be designed to bedifferent at various areas of the anchor assembly 200.

In some embodiments, the anchor assembly 200 includes features forenhanced in vivo radiographic visibility. In some embodiments, portionsof the anchor assembly 200, such as one or more of the anchor feet 220a, 220 b, 220 c, and 220 d, and/or SAM containment member 212, may haveone or more radiopaque markers attached thereto. In some embodiments,some or all portions of the anchor assembly 200 are coated (e.g.,sputter coated) with a radiopaque coating.

Still referring to FIGS. 8 and 9, as described above the anchor feet 220a, 220 b, 220 c, and 220 d are sized and shaped to engage thesub-annular gutter 19 of the mitral valve 17. In some embodiments, theanterior feet 220 a and 220 d are spaced apart from each other by adistance in a range of about 30 mm to about 45 mm, or about 20 mm toabout 35 mm, or about 40 mm to about 55 mm. In some embodiments, theposterior feet 220 b and 220 c are spaced apart from each other by adistance in a range of about 20 mm to about 30 mm, or about 10 mm toabout 25 mm, or about 25 mm to about 40 mm.

In some embodiments, the anchor feet 220 a, 220 b, 220 c, and 220 d havea height ranging from about 8 mm to about 12 mm, or more than about 12mm. In some embodiments, the anchor feet 220 a, 220 b, 220 c, and 220 dhave a gutter engaging surface area (when fabric covered) ranging fromabout 6 mm² to about 24 mm². In some embodiments, the anchor feet 220 a,220 b, 220 c, and 220 d each have essentially the same gutter engagingsurface area. In particular embodiments, one or more of the anchor feet220 a, 220 b, 220 c, and 220 d has a different gutter engaging surfacearea than one or more of the other anchor feet 220 a, 220 b, 220 c, and220 d. The anchor feet 220 a, 220 b, 220 c, and 220 d can have widthsranging within about 1.5 mm to about 4.0 mm or more, and lengths rangingwithin about 3 mm to about 6 mm or more. The anchor feet 220 a, 220 b,220 c, and 220 d are sized and shaped so that the anchor assembly 200does not significantly impair the natural function of mitral valvechordae tendineae, the native mitral valve leaflets, and papillarymuscles even after the anchor assembly is anchored at the mitral valvesite.

As described previously, the anchor assembly 200 is designed to avoidinterference with the functioning of the native mitral valve 17.Therefore, the anchor assembly 200 can be implanted within the nativemitral valve 17 some time prior to the deployment therein of areplacement valve assembly, without degradation of valve 17 functionduring the period of time between the anchor implantation and the valveimplantation (whether that time is on the order of minutes, or evenseveral days or months). To avoid such interference between the anchorassembly 200 and the native mitral valve 17, the inter-annularconnections 270 a, 270 b, 270 c, and 270 d pass through the coaptationline 32 approximately. More particularly, the lateral anteriorinter-annular connection 270 a passes through the coaptation line 32adjacent to the anterolateral commissure 30 a. In like manner, themedial anterior inter-annular connection 270 d passes through thecoaptation line 32 adjacent to the posteromedial commissure 30 b. Insome implementations, the lateral posterior inter-annular connection 270b and medial posterior inter-annular connection 270 c pass through thenative mitral valve 17 in locations that are posteriorly biased from thenatural coaptation line 32. The posterior leaflet 22 will tend tocompliantly wrap around the lateral posterior inter-annular connection270 b and medial posterior inter-annular connection 270 c to facilitatesealing of the mitral valve 17, with the anchor assembly 200 coupledthereto.

In reference to FIGS. 9 and 10, the pre-deployed and deployedconfigurations of the SAM containment member 212 are illustratedrespectively. The deployed configuration of the SAM containment member212 (shown in FIG. 10) reveals that, in this embodiment, the lateralanterior arm 213 a and the medial anterior arm 213 d are conjoined, andthat an attachment element 214 (an eyelet 214 in this embodiment) isdisposed near the junction of the lateral anterior arm 213 a and themedial anterior arm 213 d. As described further below, the eyelet 214provides an attachment element that can be used to control theconfiguration and deployment of the SAM containment member 212. In someembodiments, other types of attachment elements 214 (as alternatives tothe eyelet 214) can be included on the SAM containment member 212. Forexample, in some embodiments one or more protrusions, ball ends,recesses, clips, breakable elements, deflectable elements, bends, andthe like, and combinations thereof, can be included on the SAMcontainment member 212 as an attachment element 214.

In the depicted embodiment, the SAM containment member 212 is biasedsuch that it naturally seeks to be arranged in the deployedconfiguration. Therefore, as described further below, in someembodiments when the SAM containment member 212 is released from beingconstrained in its pre-deployed configuration, the SAM containmentmember 212 will naturally reconfigure itself (or “self-reconfigure”)into the deployed configuration (or an approximation thereof). In someembodiments, a shape-setting process is used to instill a bias so thatthe SAM containment member 212 tends seek its deployed configuration.Alternatively or additionally, as described further below, in someembodiments the SAM containment member 212 may be deflected into thedeployed configuration by the application of one or more forces duringthe deployment of the SAM containment member 212.

In some implementations, while the SAM containment member 212 isdeployed, the lateral anterior arm 213 a and/or the medial anterior arm213 d may engage with the anterior leaflet and/or chordae to reduce thelikelihood of SAM. The engagement can be anywhere along the lengths ofthe lateral anterior arm 213 a and/or the medial anterior arm 213 d, andat the juncture thereof. For example, in some implementations portionsof the lateral anterior arm 213 a and/or the medial anterior arm 213 dthat are near to the lateral anterior sub-annular support arm 230 aand/or the medial anterior sub-annular support arm 230 d can actuallyengage the lateral edge of the anterior leaflet and/or chordae to spreador widen the anterior leaflet at the lateral edges thereby restrictingits movement and also reducing likelihood of SAM.

In reference to FIG. 11, the anchor assembly 200 may additionally oralternately include another example embodiment of a SAM containmentmember 216. In the depicted embodiment, the SAM containment member 216is fixedly attached to the hub 210, and extends in a generally anteriorand superior direction from the hub 210.

The SAM containment member 216 includes an arm portion 217 attached tothe hub 210, and an end portion 218 that extends from the arm portion217. While in the depicted embodiment the arm portion 217 is a singleelongate member, in some embodiments the arm portion 217 comprises twoor more elongate members.

In some embodiments, as in the depicted embodiment, the end portion 218extending from the elongate member arm portion 217 defines a width thatis greater than the width of the arm portion 217. As described furtherbelow, the end portion 218 is configured to be disposed behind ananterior leaflet when the anchor assembly 200 is engaged with a nativemitral valve. As used herein, “behind” an anterior leaflet refers to theaortic side of the native mitral valve leaflet when the leaflet is open.

In the depicted embodiment, the end portion 218 comprises a firstelongate member 219 a, a second elongate member 219 b, and a thirdelongate member 219 c (collectively referred to hereinafter as “threeelongate members 219 a-c”). The three elongate members 219 a-c fan outfrom the arm portion 217. The three elongate members 219 a-c therebycollectively define or encompass a broad area that will make contactwith the back of the anterior leaflet of a mitral valve in situ. In someembodiments, one or more interconnecting struts may extend between thethree elongate members 219 a-c. In some embodiments, the fanned outarrangement of the three elongate members 219 a-c is the natural orunconstrained arrangement of the three elongate members 219 a-c. Asdescribed further below, prior to the deployment of the SAM containmentmember 216, the three elongate members 219 a-c may be compressed towardseach other for containment within a lumen of a low-profile deliverysheath. Upon emergence from the lumen, the three elongate members 219a-c may naturally diverge from each other into the fanned outarrangement as shown.

While the depicted embodiment of the end portion 218 includes threeelongate members 219 a-c that extend from the arm portion 217 in afanned-out arrangement, various other configurations of the end portion218 are also envisioned. For example, in some embodiments a singleelongate member makes up the end portion 218. Such a single elongatemember may be wider, narrower, or the same width as the arm portion 217.In some embodiments, the end portion may have two elongate membersarranged in a V-shape or U-shape, and the like. In some embodiments, theend portion may include four or more elongate members. In someembodiments, the end portion may be a looped member, such as a circle,oval, triangle, rectangle, and the like. In some embodiments, the endportion 218 is generally planar. In some embodiments, the end portion218 is contoured rather than planar. As with the three elongate members219 a-c described above, other configurations of the end portion 218 canbe compressed for containment within a delivery sheath, and canself-expand into a larger (e.g., broader or wider) deployedconfiguration upon emergence from the delivery sheath.

While the three elongate members 219 a-c of the depicted embodiment ofthe end portion 218 each include bulbous free ends, in some embodimentsno such bulbous free ends are included. In the depicted embodiment, thebulbous free ends of the three elongate members 219 a-c include eyelets.However, in some embodiments no such eyelets are included.

In reference to FIG. 12, in some embodiments the anchor assembly 200includes a covering material 270 disposed on one or more portions of theanchor assembly 200. The covering material 270 can provide variousbenefits. For example, in some implementations the covering material 270can facilitate tissue ingrowth and/or endothelialization, therebyenhancing the migration resistance of the anchor assembly 200 andpreventing thrombus formation on blood contact elements. In anotherexample, as described further below, the covering material 270 can beused to facilitate coupling between the anchor assembly 200 and a valveassembly that is received therein. The cover material 270 also preventsor minimizes abrasion and/or fretting between the anchor assembly 200and valve assembly 300. The cover material 270 also prevents valve outertissue abrasion related wear, and supports to the cuff material toenhance durability. The covering material 270 may also provide redundantsealing in addition to the cuff material of the valve assembly.

In the depicted embodiment, the covering material 270 is disposedessentially on the entire anchor assembly 200, including the SAMcontainment member 212 (except for the eyelet 214, although in someembodiments the eyelet 214 may be essentially covered by the coveringmaterial 270). In some embodiments, the covering material 270 isdisposed on one or more portions of the anchor assembly 200, while oneor more other portions of the anchor assembly 200 do not have thecovering material 270 disposed thereon. While the depicted embodimentincludes the covering material 270, the covering material 270 is notrequired in all embodiments. In some embodiments, two or more portionsof covering material 270, which can be separated and/or distinct fromeach other, can be disposed on the anchor assembly 200. That is, in someembodiments a particular type of covering material 270 is disposed onsome areas of the anchor assembly 200 and a different type of coveringmaterial 270 is disposed on other areas of the anchor assembly 200.

In some embodiments, the covering material 270, or portions thereof,comprises a fluoropolymer, such as an expanded polytetrafluoroethylene(ePTFE) polymer. In some embodiments, the covering material 270, orportions thereof, comprises a polyester, a silicone, a urethane,ELAST-EON™ (a silicone and urethane polymer), another biocompatiblepolymer, DACRON®, polyethylene terephthalate (PET), copolymers, orcombinations and subcombinations thereof. In some embodiments, thecovering material 270 is manufactured using techniques such as, but notlimited to, extrusion, expansion, heat-treating, sintering, knitting,braiding, weaving, chemically treating, and the like. In someembodiments, the covering material 270, or portions thereof, comprises abiological tissue. For example, in some embodiments the coveringmaterial 270 can include natural tissues such as, but not limited to,bovine, porcine, ovine, or equine pericardium. In some such embodiments,the tissues are chemically treated using glutaraldehyde, formaldehyde,or triglycidylamine (TGA) solutions, or other suitable tissuecrosslinking agents.

In the depicted embodiment, the covering material 270 is disposed on theinterior and the exterior of the anchor assembly 200. In someembodiments, the covering material 270 is disposed on the just theexterior of the anchor assembly 200. In some embodiments, the coveringmaterial 270 is disposed on the just the interior of the anchor assembly200. In some embodiments, some portions of the anchor assembly 200 arecovered by the covering material 270 in a different manner than otherportions of the anchor assembly 200.

In some embodiments, the covering material 270 is attached to at leastsome portions of the anchor assembly 200 using an adhesive. In someembodiments, epoxy is used as an adhesive to attach the coveringmaterial 270 to the anchor assembly 200, or portions thereof. In someembodiments, wrapping, stitching, lashing, banding, and/or clips, andthe like can be used to attach the covering material 270 to the anchorassembly 200. In some embodiments, a combination of techniques are usedto attach the covering material 270 to the anchor assembly 200.

In some embodiments, the covering material 270, or portions thereof, hasa microporous structure that provides a tissue ingrowth scaffold fordurable sealing and/or supplemental anchoring strength of the anchorassembly 200. In some embodiments, the covering material 270 is made ofa membranous material that inhibits or reduces the passage of bloodthrough the covering material 270. In some embodiments, the coveringmaterial 270, or portions thereof, has a material composition and/orconfiguration that inhibits or prevents tissue ingrowth and/orendothelialization to the covering material 270.

In some embodiments, the covering material 270 can be modified by one ormore chemical or physical processes that enhance certain physicalproperties of the covering material 270. For example, a hydrophiliccoating may be applied to the covering material 270 to improve thewettability and echo translucency of the covering material 270. In someembodiments, the covering material 270 may be modified with chemicalmoieties that promote or inhibit one or more of endothelial cellattachment, endothelial cell migration, endothelial cell proliferation,and resistance to thrombosis. In some embodiments, the covering material270 may be modified with covalently attached heparin or impregnated withone or more drug substances that are released in situ.

In some embodiments, covering material 270 is pre-perforated to modulatefluid flow through the covering material 270 and/or to affect thepropensity for tissue ingrowth to the covering material 270. In someembodiments, the covering material 270 is treated to make the coveringmaterial 270 stiffer or to add surface texture. In some embodiments,selected portions of the covering material 270 are so treated, whileother portions of the covering material 270 are not so treated. Othercovering material 270 material treatment techniques can also be employedto provide beneficial mechanical properties and tissue responseinteractions. In some embodiments, portions of the covering material 270have one or more radiopaque markers attached thereto to enhance in vivoradiographic visualization.

Referring now to FIGS. 13A and 14A, the anchor assembly 200 is shownimplanted within a native mitral valve 17. FIGS. 13B and 14B arephotographs that correspond to FIGS. 13A and 14A respectively. In FIG.13A, the mitral valve 17 is shown in a closed state. In FIG. 14A, themitral valve 17 is shown in an open state. These illustrations are fromthe perspective of the left atrium looking towards the mitral valve 17.For instance, in FIG. 14A chordae tendineae 40 are visible through theopen leaflets of the mitral valve 17.

These figures illustrate the supra-annular structures and sub-annularstructures of the anchor assembly 200 in their relationships with thenative mitral valve 17. For example, the closed state of the nativemitral valve 17 in FIG. 13A allows visibility of the supra-annularstructures such as the lateral anterior atrial holding feature 240 a,the lateral posterior atrial holding feature 240 b, the medial posterioratrial holding feature 240 c, and the medial anterior atrial holdingfeature 240 d. In addition, the anterior anchor arch 250 a, the leftanchor arch 250 b, the posterior anchor arch 250 c, the right anchorarch 250 d, and the connection bridges 260 are visible. However, thesub-annular structures are not visible in FIG. 13A because suchstructures are obstructed from view by the anterior leaflet 20 and thethree-part posterior leaflet 24 a, 24 b, and 24 c.

In contrast, in FIG. 14A certain sub-annular structures of the anchorassembly 200 are visible because the native mitral valve 17 is open. Forexample, sub-annular support arms 230 a, 230 b, 230 c, and 230 d and hub210 are in view through the open mitral valve 17. Nevertheless, theanchor feet 220 a, 220 b, 220 c, and 220 d remain out of view because oftheir location within the sub-annular gutter of the mitral valve 17. Inaddition, no SAM containment member (which is a sub-annular structure)is visible in this view.

Referring to FIG. 15, after implantation of the anchor assembly 200within the native mitral valve 17 (as performed, for example, inaccordance with FIGS. 1-7 described above), a valve delivery sheath 170of the delivery system 100 can be used to deploy a valve assembly withinthe anchor assembly 200. As described above in reference to FIG. 7, withthe distal pusher catheter 160 coupled with the hub 210 of the anchorassembly 200, the distal pusher catheter 160 can be used to guide thevalve assembly into the interior of the anchor assembly 200.

In the depicted embodiment, the SAM containment member 212 isconstrained in its pre-deployed configuration. However, in some otherSAM containment member embodiments (e.g., as described further below inreference to FIGS. 27-33), the SAM containment member may be deployedprior to installation of a valve assembly within the anchor assembly200. Generally speaking, depending on the SAM containment memberembodiment's design, if the SAM containment member may potentiallyinterfere with the function of the anterior leaflet, it may bepreferable to wait until the valve is implanted to deploy the SAMcontainment member. But, if the SAM containment member does not or isunlikely to interfere with the leaflet function, the SAM containmentmember may be deployed prior to valve implant (which may be beneficialfor situations where the anchor is implanted in a separate procedurefrom the valve implantation).

In some implementations, with the primary deflectable catheter 120positioned with its distal end in the left atrium 16, the valve deliverysheath 170 is installed into a lumen of the primary deflectable catheter120 (over the distal pusher catheter 160) and advanced through theprimary deflectable catheter 120. As described further below, in someembodiments the valve delivery sheath 170 is preloaded with a prostheticvalve assembly and other components of the delivery system 100. Theprimary deflectable catheter 120 may be the same catheter that was usedto deliver the anchor assembly 200, or it may be a different catheter(but still referred to here as the primary deflectable catheter 120 forsimplicity sake).

In some embodiments, the valve delivery sheath 170 can be made from thematerials described above in reference to the primary deflectablecatheter 120. In some embodiments, the valve delivery sheath 170 has anouter diameter in the range of about 20 Fr to about 28 Fr (about 6.7 mmto about 9.3 mm). In some embodiments, the valve delivery sheath 170 hasan outer diameter in the range of about 14 Fr to about 24 Fr (about 4.7mm to about 8.0 mm).

In the depicted embodiment, the valve delivery sheath 170 includes aflared distal end portion 172. In some embodiments, no such flareddistal end portion 172 is included. The flared distal end portion 172can collapse to a lower profile when constrained within the primarydeflectable catheter 120. When the flared distal end portion 172 isexpressed from the primary deflectable catheter 120, the flared distalend portion 172 can self-expand to the flared shape. In someembodiments, the material of the flared distal end portion 172 includespleats or folds, may be a continuous flared end or may be separated intosections such as flower pedals, and may include one or more resilientelements that bias the flared distal end portion 172 to assume theflared configuration in the absence of restraining forces (such as fromcontainment within the primary deflectable catheter 120). The flareddistal end portion 172 can be advantageous, for example, for recapturingthe valve assembly within the lumen of the valve delivery sheath 170after the valve assembly has been expressed from the flared distal endportion 172.

In some embodiments, the maximum outer diameter of the flared distal endportion 172 is in a range of about 30 Fr to about 34 Fr (about 10.0 mmto about 11.3 mm). In some embodiments, the maximum outer diameter ofthe flared distal end portion 172 is in a range of about 32 Fr to about44 Fr (about 10.7 mm to about 14.7 mm). In some embodiments, the maximumouter diameter of the flared distal end portion 172 is in a range ofabout 24 Fr to about 30 Fr (about 8.0 mm to about 10.0 mm). In someembodiments, the maximum outer diameter of the flared distal end portion172 is less than about 24 Fr (about 8.0 mm) or greater than about 44 Fr(about 14.7 mm).

Referring to FIG. 16, in some implementations the valve delivery sheath170 can be withdrawn into the primary deflectable catheter 120 while avalve delivery catheter 180 is held substantially stationary to expressa valve assembly 300 from a lumen of the valve delivery sheath 170. Thevalve delivery sheath 170 and the valve delivery catheter 180 areadditional components in some embodiments of the example delivery system100.

The valve assembly 300 can be releasably coupled to the valve deliverycatheter 180 and retained in a low-profile configuration. In someembodiments, both the distal and proximal ends of the valve assembly 300are releasably coupled to the valve delivery catheter 180. In someembodiments, just one of the distal end or the proximal end of the valveassembly 300 is releasably coupled to the valve delivery catheter 180.In particular embodiments, one or more control wires may be included toreleasably couple one or more portions of the valve assembly 300 to thevalve delivery catheter 180.

Referring to FIGS. 17 and 18, the delivery system 100 can be manipulatedby a clinician operator to perform a lateral pivot (panning, rotation,etc.) of the valve assembly 300 within the left atrium 16. The rotationof the valve assembly 300 changes the alignment of the valve assembly300 from being generally axial with the distal end portion of theprimary deflectable catheter 120 to being generally axial with theanchor assembly 200 (in preparation for installation of the valveassembly 300 into the interior of the anchor assembly 200).

In some implementations, the aforementioned rotation of the valveassembly 300 can be performed as follows. As shown in FIG. 17, becauseof the influence from the primary deflectable catheter 120 on the valvedelivery catheter 180, the axis of the valve assembly 300 is initiallyin general alignment with the axis of the distal end portion of theprimary deflectable catheter 120. From this arrangement, a simultaneouscounter movement between the distal pusher catheter 160 and the valvedelivery catheter 180 can be performed by the clinician to rotate thevalve assembly 300. That is, as the distal pusher catheter 160 is pulledproximally, the valve delivery catheter 180 is pushed distally. As aresult of that counter movement, the valve assembly 300 rotates in arelatively tight radius, as required by the confines of the left atrium16. Thereafter, the valve delivery catheter 180 can be advanced furtherso that the valve assembly 300 is coaxially positioned within theinterior of the anchor assembly 200 as shown in FIG. 18.

Referring now also to FIG. 19, in some embodiments the valve assembly300 and the anchor assembly 200 become aligned with each othercoaxially, linearly (along their axes), and rotationally prior to orduring the expansion of the valve assembly 300, resulting in engagementbetween the valve assembly 300 and the anchor assembly 200.

Coaxial alignment between the valve assembly 300 and the anchor assembly200, as described above, is achieved by virtue of the valve deliverycatheter 180 being slidably disposed over the distal pusher catheter160. Linear alignment between the valve assembly 300 and the anchorassembly 200 can be achieved by the interaction of a distal end feature182 of the valve delivery catheter 180 and the hub 210 of the anchorassembly 200. For example, in some embodiments an abutting of the distalend feature 182 and the hub 210 can result in proper linear alignmentbetween the valve assembly 300 and the anchor assembly 200.

Relative rotational alignment between the valve assembly 300 and theanchor assembly 200 (about their axes) can be achieved in variousmanners. For example, in some embodiments the valve delivery catheter180 is mechanically keyed to the distal pusher catheter 160 to slidablyfix a desired rotational alignment between the valve assembly 300 andthe anchor assembly 200. In some embodiments, other types of mechanicalfeatures (e.g., pins/holes, protrusions/receptacles, etc.) can beincluded to facilitate a desired rotational/spin alignment between thevalve assembly 300 and the anchor assembly 200. Alternatively, oradditionally, radiopaque markers can be included on the valve assembly300 and on the anchor assembly 200 (including on the SAM containmentmember) in locations and/or patterns that are indicative of the relativerotational orientation (about their axes) of the valve assembly 300 andthe anchor assembly 200. In some embodiments, (e.g., when the valvedelivery catheter 180 “torqueable”) the valve delivery catheter 180 canbe rotated about its axis until the markers are in proper positionrelative to the anchor assembly 200, prior to final expansion of valveassembly 300. Fluoroscopy can be used to attain a desired relativeorientation of the radiopaque markers, and of the valve assembly 300 andthe anchor assembly 200 (including on the SAM containment member)correspondingly.

In the depicted implementation, the SAM containment member 212 is stillin its pre-deployed configuration. Therefore, the depicted embodiment ofthe SAM containment member 212 is deployed after the valve assembly 300is engaged within the anchor assembly 200. However, for some alternativeembodiments of the SAM containment member (as described further below)the SAM containment member is deployed prior to the engagement of thevalve assembly 300 within the anchor assembly 200.

Referring to FIGS. 20 and 21, the SAM containment member 212 of theanchor assembly 200 can be configured in a pre-deployed configurationand a deployed configuration. FIG. 20 shows the SAM containment member212 in the pre-deployed configuration, and FIG. 21 shows the SAMcontainment member 212 in the deployed configuration. As describedfurther below, in some embodiments the deployment of the SAM containmentmember 212 takes place after the anchor assembly 200 and after the valveassembly 300 are installed in the native mitral valve (as describedabove in reference to FIGS. 1-19). Here, for simplicity, the valveassembly 300 is not shown. This technique for deploying the SAMcontainment member 212 results in the positioning of the SAM containmentmember 212 anteriorly to (also referred to herein as “behind”) thenative mitral valve anterior leaflet. Accordingly, the deployed SAMcontainment member 212 acts as a physical barrier that inhibits and/orprevents the native mitral valve anterior leaflet from obstructing theLVOT.

It is envisioned that the deployment of the SAM containment member 212can be performed in a controlled manner by the use of various mechanismsand techniques that are all within the scope of this disclosure.Multiple non-limiting examples of such SAM containment and deploymentmechanisms and techniques are provided herein.

As described above, in some embodiments the transcatheter mitral valvedelivery system 100 includes the distal pusher catheter 160 and theguidewire 110. In some embodiments, the guidewire 110 is slidablydisposed within a lumen of the distal pusher catheter 160, and theguidewire 110 can extend distally out from the distal end of the distalpusher catheter 160. As in the depicted embodiment, in some embodimentsthe guidewire 120 can extend through the eyelet 214 of the SAMcontainment member 212.

In the example embodiment depicted in FIGS. 20 and 21, the distal pushercatheter 160 includes a threaded distal end 162 out of which theguidewire 110 can distally extend. As depicted, in some embodiments thethreaded distal end 162 can be mated with complementary internal threadswithin the eyelet 214 of the SAM containment member 212. Accordingly,the threaded distal end 162 can be selectively threaded into engagementwith the eyelet 214, and selectively unthreaded from engagement with theeyelet 214. Said another way, in some embodiments the distal pushercatheter 160 is releasably engageable with the SAM containment member212. A clinician that is performing the process of deploying the anchorassembly 200 can thereby control the deployment of the SAM containmentmember 212. In other words, by turning the distal pusher catheter 160the clinician can unthread the threaded distal end 162 from the eyelet214 to release or deploy the SAM containment member 212.

When the threaded distal end 162 is coupled with the eyelet 214, the SAMcontainment member 212 is restrained in its pre-deployed configuration(FIG. 20). When the threaded distal end 162 is uncoupled from the eyelet214, the SAM containment member 212 is released from constraint by thedistal pusher catheter 160, and the SAM containment member 212 is thenfree to seek its natural deployed configuration (FIG. 21).

In some implementations, while the SAM containment member 212 isdeployed, portions of the SAM containment member 212 may engage with theanterior leaflet and/or chordae to reduce the likelihood of SAM. Theengagement can be anywhere along the lengths of the lateral anterior arm213 a and/or the medial anterior arm 213 d, and at the juncture thereof(e.g., refer to FIG. 10). For example, in some implementations portionsof the lateral anterior arm 213 a and/or the medial anterior arm 213 dthat are near to the lateral anterior sub-annular support arm 230 aand/or the medial anterior sub-annular support arm 230 d can actuallyengage the lateral edge of the anterior leaflet and/or chordae to spreador widen the anterior leaflet at the lateral edges, thereby restrictingits movement and also reducing likelihood of SAM.

Referring to FIGS. 22-24, the deployment process of the SAM containmentmember 212, while the prosthetic mitral valve 400 is engaged with thenative mitral valve 17 (as described above), will now be describedfurther. FIG. 22 shows the position of the SAM containment member 212after detachment from the distal pusher catheter 160 but prior tosubstantial movement of the SAM containment member 212 from itsconstrained pre-deployed configuration. FIG. 23 depicts the interimposition of the SAM containment member 212 as it is moving to (orself-deflecting to) its natural deployed configuration. FIG. 24 showsthe position of the SAM containment member 212 in its deployedconfiguration where the SAM containment member 212 is at least partiallydisposed behind anterior leaflet 20 (i.e., on the aortic side ofanterior leaflet 20). Therefore, this series of figures depicts thedeployment process (or “self-reconfiguring” process) of the SAMcontainment member 212 post-decoupling from the distal pusher catheter160.

These figures include depictions of the prosthetic mitral valve 400(including the anchor assembly 200 that is coupled or mated with thevalve assembly 300), the distal pusher catheter 160 and the guidewire110 (which are component members of a delivery system), the nativemitral valve 17 of a patient, and the anterior leaflet 20 of the nativemitral valve 17. It should be noted that in this implementation, thedeployment of the SAM containment member 212 is taking place after theprosthetic mitral valve 400 (including the anchor assembly 200 coupledor mated with the valve assembly 300) is engaged in an operativeposition with the native mitral valve 17. Alternatively, in someimplementations the deployment of the SAM containment member 212 cantake place after the engagement of the anchor assembly 200 with thenative mitral valve 17, but prior to the coupling/mating of the valveassembly 300 with the anchor assembly 200.

In some embodiments, the guidewire 110 is engaged with an attachmentelement of the SAM containment member 212. For example, in the depictedembodiment the guidewire 110 is threaded through the eyelet 214 of theSAM containment member 212. Accordingly, after detachment of the distalpusher catheter 160 from the SAM containment member 212, the guidewire110 remains slidably engaged with the SAM containment member 212.

In some implementations, the fact that the guidewire 110 can remainengaged with the SAM containment member 212 after detachment from thedistal pusher catheter 160 enables the guidewire 110 to be used to exertsome control over the deployment of the SAM containment member 212. Forexample, by constructing the guidewire 110 to have two or more portionsof differing lateral flexibility, the self-reconfiguration of the SAMcontainment member 212 can be at least partially controlled orinfluenced by the longitudinal positioning of the guidewire 110. In onesuch example, the guidewire 110 has a distal tip portion that is morelaterally flexible than a stiffer portion that is proximal from thedistal tip portion. Accordingly, when the stiffer portion of theguidewire 110 is engaged with the SAM containment member 212, theguidewire 110 restrains or partially restrains the SAM containmentmember 212 from moving to its fully deployed configuration. However,when the guidewire 110 is pulled back (proximally) so that the morelaterally flexible portion of the guidewire 110 becomes engaged with theSAM containment member 212, then the bias of the SAM containment member212 to self-reconfigure to its natural deployed configuration mayovercome the lateral resistance from the guidewire 110. Therefore, by aclinician's selective positioning of the guidewire 110 relative to theSAM containment member 212, the deployment of the SAM containment member212 can be at least partially controlled by the clinician.

As seen in FIG. 23, in some implementations as the SAM containmentmember 212 begins to reconfigure (or is partially reconfigured), theguidewire 110 may be thereby deflected into a position thatadvantageously contacts the back of the native anterior leaflet 20. As aresult, the guidewire 110 may serve to draw or restrain the anteriorleaflet 20 radially inward towards the prosthetic mitral valve 400, thusfacilitating the capture of the anterior leaflet 20 during thedeployment of the SAM containment member 212.

As seen in FIG. 24, when the SAM containment member 212 is configured inits deployed configuration, at least a portion of the SAM containmentmember 212 is disposed behind the anterior leaflet 20 of the nativemitral valve 17. In some implementations, the anterior leaflet 20 isloosely contained in the space defined between the SAM containmentmember 212 and an exterior surface of the valve assembly 300.Accordingly, the potential for systolic anterior motion (SAM) of theanterior leaflet 20 is managed or controlled. That is, the anteriorleaflet 20 is restrained from causing LVOT obstruction or the creationof high LVOT pressure gradients by the positioning of the SAMcontainment member 212 behind the anterior leaflet 20.

Referring to FIGS. 25 and 26, in some embodiments a control wire 164 ofa delivery system 100 (e.g., refer to FIGS. 1-7 and 15-19) can bedetachably coupled with the SAM containment member 212 so that aclinician can control the deployment of the SAM containment member 212.For example, in some embodiments the control wire 164 is coupled with anattachment element of the SAM containment member 212 (such as bythreading the control wire 164 through the eyelet 214, in someembodiments).

In some embodiments, the control wire 164 is slidably disposed within alumen of the distal pusher catheter 160. In particular embodiments, thecontrol wire 164 is disposed exterior to the distal pusher catheter 160.

In some embodiments, the two ends of the control wire 164 can bepositioned external to the patient such that the clinician operator canlongitudinally adjust the position of the control wire 164, to therebycontrol the deployment positioning of the SAM containment member 212 (asdepicted by comparing FIG. 25 with FIG. 26). For example, while bothends of the control wire 164 can be pulled and/or restrained proximallyto position the SAM containment member 212 in its pre-deployedconfiguration (FIG. 25), one or both ends of the control wire 164 canalso be moved or allowed to move distally to facilitate or encouragereconfiguration of the SAM containment member 212 to its deployedconfiguration (FIG. 26).

It should be understood that, using the control wire 164, the cliniciancan precisely control the deployment of the SAM containment member 212.For example, the clinician can thereby control the pace of thereconfiguration of the SAM containment member 212. Further, after theSAM containment member 212 has been deployed or partially deployed, theclinician can reverse-deploy the SAM containment member 212 (that is,pull the control wire 164 proximally so that the SAM containment member212 returns partially or fully to the pre-deployed configuration). Inthis manner, the deployment process of the SAM containment member 212 isreversible and repeatable (as long as the control wire 164 remainscoupled with the SAM containment member 212).

When the clinician operator deems that the SAM containment member 212has been satisfactorily configured (e.g., such that at least a portionof the SAM containment member 212 is positioned behind the anteriorleaflet), the clinician can then pull one end of the control wire 164while releasing the other end of the control wire 164. By continuing topull on the one end of the control wire 164, the control wire 164 can beeventually detached (e.g., unthreaded) from the SAM containment member212.

Referring to FIGS. 27-34, in some implementations a SAM containmentmember 216 (refer to FIG. 11) can be deployed while the anchor assembly200 is engaged with the native mitral valve 17 (as described above). Itshould be understood that, in some implementations, the deploymentprocess of the SAM containment member 216 can take place prior to thedeployment of the valve assembly 300 (e.g., as depicted in FIG. 34).Alternatively, in some implementations the deployment process of the SAMcontainment member 216 can take place after the valve assembly 300 ismated with the anchor assembly 200. The embodiment depicted in FIGS.27-34 is well suited for deployment prior to the artificial valveassembly 300 implementation, as its design, which emanates from the hub210 has little impact on the normal function of the anterior leaflet,and allows the anterior leaflet to continue to function essentiallynormally prior to the implantation of the valve assembly 300.

FIGS. 27, 29, and 30 show the position of the SAM containment member 216in its pre-deployed configuration within a sheath 166. FIGS. 31 and 32show the position of the SAM containment member 216 in itspartially-deployed configuration after emergence from the sheath 166,but prior to receiving a deformation force from the sheath 166. FIGS.28, 33, and 34 show the position of the SAM containment member 216 inits deployed configuration after being deformed thereto by a deformationforce applied via the sheath 166.

The SAM containment member 216 comprises an elongate element arm portion217 (attached to the hub 210 of the anchor assembly 200) and an endportion 218 that extends from the arm portion 217. In some embodiments,the end portion 218 extending from the elongate member arm portion 217defines a width that is greater than the width of the arm portion 217.As described further below, the end portion 218 is configured to bedisposed behind an anterior leaflet when the anchor assembly 200 isengaged with a native mitral valve.

As shown in FIGS. 27, 29, and 30, in some embodiments the SAMcontainment member 216 can be arranged in a pre-deployed configurationwhere it is slidably disposed within a lumen of a sheath 166 in alow-profile configuration suitable for transcatheter delivery. In someembodiments, the distal pusher catheter 160 is also slidably disposedwithin the sheath 166. With the SAM containment member 216 constrainedin this pre-deployed configuration, the anchor assembly 200 can beexpanded and engaged within the native mitral valve 17 as depicted inFIG. 29.

In some implementations, after the engagement of the anchor assembly 200with the native mitral valve 17, the deployment process of the SAMcontainment member 216 can be performed. First, as shown in FIGS. 31 and32, the sheath 166 can be pulled proximally by a clinician operator toallow the SAM containment member 216 to emerge from containment withinthe sheath 166. When the sheath 166 is pulled back, in some embodimentsthe natural bias of the SAM containment member 216 causes the SAMcontainment member 216 to deflect radially away from its previousposition within the sheath 166. Additionally, due to the removal of thediametrically constraining sheath 166, in some embodiments the endportion 218 expands to the natural unconstrained configuration of theend portion 218. For example, in the depicted embodiment the threeelongate members 219 a-c fan out laterally to define a width that isgreater than the width of the arm portion 217.

In some embodiments, the next step of the deployment process of the SAMcontainment member 216 comprises further radial deflection of the SAMcontainment member 216, so that the end portion 218 becomes disposedbehind the anterior leaflet 20. This step is depicted in FIGS. 28 and33, and can be performed under fluoroscopy (as can some or all of theother deployment steps described herein).

In some implementations, this step of further radial deflection of theSAM containment member 216 is performed at least in part by theapplication of a force from the sheath 166 to the arm portion 217. Thatis, in some embodiments the sheath 166 includes a distal end 167 that isconfigured to interface with the arm portion 217, and to apply a forcethereto that results in radial deflection of the SAM containment member216. For example, in some embodiments when the clinician operator pushesthe sheath 166 distally, the distal end 167 presses on the arm portion217 to cause a radial deflection of the SAM containment member 216.

In some embodiments, the deflection of the SAM containment member 216 sothat the end portion 218 becomes disposed behind the anterior leaflet 20occurs by plastic deformation of the SAM containment member 216 as aresult of the forces applied thereto by the sheath 166. In variousembodiments, the deflection of the SAM containment member 216 so thatthe end portion 218 becomes disposed behind the anterior leaflet 20occurs by the natural bias of the SAM containment member 216 after theSAM containment member 216 is allowed to emerge from the sheath 166, andwithout additional forces applied by the sheath 166. In particularembodiments, the deflection of the SAM containment member 216 so thatthe end portion 218 becomes disposed behind the anterior leaflet 20 isachieved by a combination of the natural bias of the SAM containmentmember 216 after the SAM containment member 216 is allowed to emergefrom the sheath 166, and further urging thereof as a result of theforces applied to the arm portion 217 by the sheath 166.

In some implementations, after the deployment of the SAM containmentmember 216 so that the end portion 218 becomes disposed behind theanterior leaflet 20, the valve assembly 300 is then deployed to matewith the anchor assembly 200 as depicted in FIG. 34. Alternatively, insome implementations the SAM containment member 216 is deployed so thatthe end portion 218 becomes disposed behind the anterior leaflet 20after the valve assembly 300 has been deployed to mate with the anchorassembly 200. In some implementations, the anterior leaflet 20 isloosely contained in the space defined between the SAM containmentmember 216 and an exterior surface of the valve assembly 300. In someimplementations, the anterior leaflet 20 is snuggly contained or lightlycompressed in the space defined between the SAM containment member 216and an exterior surface of the valve assembly 300.

Referring to FIGS. 35 and 36, an example valve assembly 300 is shownwithout any covering or valve/occluder leaflets. Hence, a valve assemblyframe 301 of the valve assembly 300 is shown. FIG. 35 shows an anteriorside view of the valve assembly frame 301, and FIG. 36 shows a bottomview of the valve assembly frame 301. The valve assembly 300 can beconstructed using any of the various materials and manufacturingtechniques described above in reference to the anchor frame 200 (e.g.,refer to FIG. 9). It should be understood that the depicted valveassembly 300 is merely one non-limiting example of the valve assembliesprovided within the scope of this disclosure.

The valve assembly 300 includes a proximal end portion 302 and a distalend portion 304. The valve assembly includes a flared external skirtportion 303 and defines an interior orifice portion 305. When the valveassembly 300 is implanted in a native mitral valve, the proximal endportion 302 is located supra-annular (in the left atrium) and the distalend portion 304 is located sub-annular (in the left ventricle). Theproximal end portion 302 defines the generally circular entrance orificeof the valve assembly 300, as described further below.

In the depicted embodiment, the valve assembly 300 generally flaresoutward along a distal direction. Said differently, the distal endportion 304 is flared outward in comparison to the proximal end portion302. Accordingly, the proximal end portion 302 defines a smaller outerprofile in comparison to the distal end portion 304. However, someregions of the distal end portion 304 bow inwardly. In particular, forexample, a posteromedial commissural corner 330 a and anterolateralcommissural corner 330 b of the valve assembly 300 may bow inwardly. Itshould be understood that the outward flare of the distal end portion304 in comparison to the proximal end portion 302 is merely one exampleconfiguration for a profile of the valve assembly 300. In someembodiments, for example, a shoulder (a portion of the valve assembly300 having the largest outer periphery) is located proximal of themiddle of the valve assembly 300.

The valve assembly 300 also includes an anterior side 306 between theposteromedial commissural corner 330 a and anterolateral commissuralcorner 330 b. When the valve assembly 300 is implanted in a nativemitral valve, the anterior side 306 faces the anterior leaflet of thenative mitral valve. The anterior side 306 of the distal end portion 304defines a generally flat surface, whereas the other sides of the distalend portion 304 are rounded. Hence, the periphery of the distal endportion 304 is generally D-shaped. The D-shaped periphery of the distalend portion 304 provides the valve assembly 300 with an advantageousouter profile for interfacing and sealing with the native mitral valve.As described further below, sealing is attained by coaptation betweenthe D-shaped periphery of the distal end portion 304 and the leaflets ofthe native mitral valve, and, in some embodiments, between the D-shapedperiphery in the region of the skirt 303 with the native valve annulus.

In the depicted embodiment, the proximal end portion 302 of the valveassembly 300 includes three atrial leaflet arches 310 a, 310 b, and 310c that together define an undulating ring at the proximal end portion302. Each of the leaflet arches 310 a, 310 b, and 310 c includes an apexhaving an attachment hole 312 a, 312 b, and 312 c respectively. In someembodiments, the attachment holes 312 a, 312 b, and 312 c are used forcoupling the proximal end of the valve assembly 300 to a deliverycatheter (e.g., valve delivery catheter 180 of FIGS. 16-18).

The valve assembly 300 also includes three commissural posts 320 a, 320b, and 320 c that each extend distally from the intersections of thethree leaflet arches 310 a, 310 b, and 310 c. The commissural posts 320a, 320 b, and 320 c are disposed at about 120° apart from each other.The commissural posts 320 a, 320 b, and 320 c each have a series ofholes that can be used for attachment of leaflets, such as by suturing.The three leaflet arches 310 a, 310 b, and 310 c and the threecommissural posts 320 a, 320 b, and 320 c are areas on the valveassembly 300 to which three prosthetic valve leaflets become attached tocomprise a tri-leaflet occluder (e.g., refer to FIGS. 38-41).

As best seen in FIG. 36, the three leaflet arches 310 a, 310 b, and 310c and the commissural posts 320 a, 320 b, and 320 c define a generallycylindrical frame for the tri-leaflet occluder construct. As such, thevalve assembly 300 provides a proven and advantageous frameconfiguration for the tri-leaflet occluder. The tri-leaflet occluderprovides open flow during diastole and occlusion of flow during systole.

Referring to FIG. 37, an exploded depiction of an example prostheticmitral valve 400 includes an anchor assembly 200 and a valve assembly300. This figure provides a posterior side view of the anchor assembly200 and the valve assembly 300.

The valve assembly 300 includes a covering 340. The covering 340 can bemade of any of the materials and constructed using any of the techniquesdescribed above in reference to covering 270. Additionally, in someembodiments the covering 340 can comprise natural tissues such as, butnot limited to, bovine, porcine, ovine, or equine pericardium. In somesuch embodiments, the tissues are chemically cross-linked usingglutaraldehyde, formaldehyde, or triglycidyl amine solution, or othersuitable crosslinking agents.

When the valve assembly 300 and the anchor assembly 200 are coupledtogether, the valve assembly 300 is geometrically interlocked within theinterior of the anchor assembly 200 (e.g., in some embodiments by virtueof the tapered shape of the valve assembly 300 within the supra-annularring and interior space of the anchor assembly 200). In particular, insome embodiments the valve assembly 300 is contained within the interiorspace between the supra-annular ring 250 and the sub-annular supportarms 230 a, 230 b, 230 c, and 230 d. As described above, the interlockedarrangement between the valve assembly 300 and the anchor assembly 200is accomplished by positioning a valve assembly 300 in a low-profileconfiguration within the interior of the anchor assembly 200 and thenallowing expansion of the valve assembly 300 within the interior of theanchor assembly 200 (e.g., refer to FIGS. 18 and 19).

Referring to FIGS. 38 and 39, a deployed configuration of the exampleprosthetic mitral valve 400 includes the valve assembly 300 engagedwithin the anchor assembly 200. FIG. 38 shows a top (atrial) view of theprosthetic mitral valve 400, and FIG. 39 shows a bottom (ventricle) viewof the prosthetic mitral valve 400.

In some embodiments, such as the depicted embodiment, valve assembly 300includes three leaflets 350 a, 350 b, and 350 c that perform theoccluding function of the prosthetic mitral valve 400. The cusps of thethree leaflets 350 a, 350 b, and 350 c are fixed to the three atrialleaflet arches 310 a, 310 b, and 310 c, and to the three commissuralposts 320 a, 320 b, and 320 c (refer to FIGS. 35 and 36). The free edgesof the three leaflets 350 a, 350 b, and 350 c can seal by coaptationwith each other during systole and open during diastole.

The three leaflets 350 a, 350 b, and 350 c can be comprised of naturalor synthetic materials. For example, the three leaflets 350 a, 350 b,and 350 c can be comprised of any of the materials described above inreference to the covering 340, including the natural tissues such as,but not limited to, bovine, porcine, ovine, or equine pericardium. Insome such embodiments, the tissues are chemically cross-linked usingglutaraldehyde, formaldehyde, or triglycidyl amine solution, or othersuitable crosslinking agents. In some embodiments, the leaflets 350 a,350 b, and 350 c have a thickness in a range of about 0.005″ to about0.020″ (about 0.13 mm to about 0.51 mm), or about 0.008″ to about 0.012″(about 0.20 mm to about 0.31 mm). In some embodiments, the leaflets 350a, 350 b, and 350 c have a thickness that is less than about 0.005″(about 0.13 mm) or greater than about 0.020″ (about 0.51 mm).

In some embodiments, the occluding function of the prosthetic mitralvalve 400 can be performed using configurations other than a tri-leafletoccluder. For example, bi-leaflet, quad-leaflet, or mechanical valveconstructs can be used in some embodiments.

In some embodiments, a SAM containment member is included as part of theanchor assembly 200 (e.g., refer to FIGS. 10 and 11). In the depictedembodiment, no SAM containment member is included.

Referring to FIGS. 40 and 41, the prosthetic mitral valve 400 is shownimplanted within a native mitral valve 17. In FIG. 40, the prostheticmitral valve 400 is shown in a closed state (occluded). In FIG. 41, theprosthetic mitral valve 400 is shown in an open state. Theseillustrations are from the perspective of the left atrium lookingtowards the mitral valve 17. For instance, in FIG. 41 the hub 210 andthe sub-annular support arms 230 a, 230 b, 230 c, and 230 d of theanchor assembly 200 are visible through the open leaflets 350 a, 350 b,and 350 c of the prosthetic mitral valve 400, whereas in FIG. 40 the hub210 and the sub-annular support arms 230 a, 230 b, 230 c, and 230 d arenot visible because the closed leaflets 350 a, 350 b, and 350 c blockthe hub 210 from view.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

What is claimed is:
 1. A prosthetic mitral valve system comprising: avalve assembly comprising an expandable valve frame and leafletsattached to the expandable valve frame; and an anchor assemblycomprising an expandable anchor frame, the anchor assembly configured tocouple with the expandable valve frame, the expandable anchor framecomprising: a containment member that is configured to be at leastpartially disposed behind an anterior leaflet of a native mitral valvewhen the expandable anchor frame is engaged with the native mitralvalve; a hub member located at an end of the expandable anchor frame;and a plurality of elongate members attached to and extending from thehub member, each elongate member including a sub-annular projectionconfigured to engage tissue proximate to an annulus of the native mitralvalve when the expandable anchor frame is in an expanded configuration,wherein the containment member is attached to and extends between twoadjacent elongate members.
 2. The prosthetic mitral valve system ofclaim 1, wherein the expandable valve frame of the valve assembly isconfigured to be in a collapsed condition positioned inwardly of theexpandable anchor frame of the anchor assembly when the expandableanchor frame is engaged with the native mitral valve, and the expandablevalve frame of the valve assembly is configured to subsequently expandwhen positioned inwardly of the expandable anchor frame of the anchorassembly so as to couple the anchor assembly and the valve assembly. 3.The prosthetic mitral valve system of claim 2, wherein a space isdefined between an outwardly facing periphery of the valve assembly andthe containment member that is configured to loosely contain theanterior leaflet when the prosthetic mitral valve system is engaged withthe native mitral valve.
 4. The prosthetic mitral valve system of claim1, wherein the containment member further comprises an attachmentelement.
 5. The prosthetic mitral valve system of claim 4, furthercomprising a delivery system for deploying the anchor assembly, whereinthe delivery system comprises a catheter with a threaded distal endportion that is configured to threadedly engage with a complimentarilythreaded eyelet defined by the attachment element.
 6. The prostheticmitral valve system of claim 4, further comprising a delivery system fordeploying the anchor assembly, wherein the delivery system comprises acontrol wire configured to engage with the attachment element.
 7. Theprosthetic mitral valve system of claim 1, wherein the expandable anchorframe includes a single containment member.
 8. A prosthetic mitral valvesystem comprising: an expandable frame with leaflets coupled thereto,wherein the expandable frame comprises: a containment member that isconfigured to be at least partially disposed behind an anterior leafletof a native mitral valve when the expandable frame is engaged with thenative mitral valve, the containment member comprising an attachmentelement; a hub member located at an end of the expandable frame; and aplurality of elongate members attached to and extending from the hubmember, each elongate member including a sub-annular projectionconfigured to engage tissue proximate to an annulus of the native mitralvalve when the expandable frame is engaged with the native mitral valve,wherein the containment member is attached to and extends between twoadjacent elongate members; and a delivery system for transcatheterdeployment of the expandable frame within the native mitral valve,wherein the delivery system is releasably coupleable with the attachmentelement.
 9. The prosthetic mitral valve system of claim 8, wherein theattachment element comprises an eyelet.
 10. The prosthetic mitral valvesystem of claim 9, wherein the eyelet includes eyelet threads, andwherein the delivery system comprises a member with threads that arecomplementary with the eyelet threads.
 11. The prosthetic mitral valvesystem of claim 9, wherein the delivery system comprises a control wirethat engages with the eyelet.
 12. The prosthetic mitral valve system ofclaim 8, wherein the expandable frame includes a single containmentmember, and the expandable frame is an expandable anchor frame; andwherein the leaflets are mounted to an expandable valve frame of a valveassembly, the expandable valve frame being configured to be in acollapsed condition positioned inwardly of the expandable anchor framewhen the expandable anchor frame is engaged with the native mitralvalve, and the expandable valve frame of the valve assembly isconfigured to subsequently expand when positioned inwardly of theexpandable anchor frame so as to couple the expandable anchor frame andthe leaflets of the valve assembly.
 13. An anchor assembly of aprosthetic mitral valve system, the anchor assembly comprising: anexpandable anchor frame that is adjustable between a radially compresseddelivery condition and a radially expanded deployed condition in whichthe expandable anchor frame is configured to engage with a native mitralvalve, the anchor assembly configured to mate with a valve assembly of aprosthetic mitral valve system, wherein the expandable anchor framecomprises: a containment member that is configured to be at leastpartially disposed behind an anterior leaflet of the native mitral valvewhen the expandable anchor frame is engaged with the native mitralvalve; a hub member located at an end of the expandable anchor frame;and a plurality of elongate members attached to and extending from thehub member, each elongate member including a sub-annular projectionconfigured to engage tissue proximate to an annulus of the native mitralvalve when the expandable anchor frame is in an expanded configuration,wherein the containment member is attached to and extends between twoadjacent elongate members.
 14. The anchor assembly of claim 13, whereinthe containment member further comprises an attachment elementconfigured to releasably engage with a portion of a delivery system. 15.The anchor assembly of claim 14, wherein the attachment elementcomprises an eyelet.
 16. The anchor assembly of claim 13, wherein theexpandable anchor frame includes a single containment member.